# ketryx.com > AI-optimized mirror of ketryx.com containing 428 pages totalling 153,099 words of clean markdown content, structured data, and semantic HTML. Original source: https://ketryx.com/. Last updated: 2026-05-25T16:31:46.518Z. Each page is available as HTML (with JSON-LD structured data) and Markdown (text-only, ideal for LLMs and RAG). ## Homepage - [site-root.html](/site-root.html) (1 words) ## Articles & Blog Posts - [platform/index.html](/platform/index.html) (1 words) - [blog/the-compliance-confidence-trap-what-100-requirements-reviews-still-miss.html](/blog/the-compliance-confidence-trap-what-100-requirements-reviews-still-miss.html) (1 words) - [capabilities/jira-connector/index.html](/capabilities/jira-connector/index.html) (1 words) - [Built for Teams Like Yours](/learn/case-studies/index.html) (185 words) - [capabilities/ai-agents/index.html](/capabilities/ai-agents/index.html) (1 words) - [blog/understanding-the-fdas-2026-clinical-decision-support-software-guidance-what-medical-device-companies-need-to-know.html](/blog/understanding-the-fdas-2026-clinical-decision-support-software-guidance-what-medical-device-companies-need-to-know.html) (1 words) - [Accelerate Product Innovation With AI](/on-demand-demo/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11, Route your prospects through Chili Piper (924 words) - [Ketryx MCP](/capabilities/ketryx-mcp/index.html): Build with FDA compliance and ALM software 3x faster with Ketryx Compliance Framework. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (668 words) - [AI Agents for Regulated Software Teams](/capabilities/ai-agents/index.html): Build with FDA compliance and ALM software 3x faster with Ketryx Compliance Framework. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11, Use Loom to record quick videos of your screen and cam. Explain anything clearly and easily – and skip the meeting. An essential tool for hybrid workplaces., Use Loom to record quick videos of your screen and cam. Explain anything clearly and easily – and skip the meeting. An essential tool for hybrid workplaces., Hi there! In this video, I’m excited to show you how our Kettrix AI Requirement Conflict Agent works. We’ll explore how it identifies and resolves conflicting requirements, using a hypothetical insulin delivery system as an example. I’ll walk you through the agent's workflow, including its recommendations for resolving conflicts. Please take a moment to review the findings and consider how this can streamline your processes., Use Loom to record quick videos of your screen and cam. Explain anything clearly and easily – and skip the meeting. An essential tool for hybrid workplaces., Hi there! In this video, I’m excited to show you how our Ketrix AI agent, specifically the Change Request Review agent, works to enhance the change request process. We’ll explore how it identifies incomplete requests and provides recommendations, which can save you significant time and effort. I encourage you to consider how this tool can help streamline your workflow and reduce documentation time by up to 90%. Let’s dive in!, Hi there! In this video, I’m excited to show you how our Kettrix AI Test Coverage agent works. It scans your tests and requirements to identify any gaps in traceability, ensuring that everything needing a test is covered. I’ll walk you through an example using a hypothetical software-as-a-medical-device product, highlighting how the agent provides recommendations for resolving missing links. Please take a moment to review the findings and consider how this can streamline your workflow!, In this video, I’m excited to show you how our Complaint Agent works to enhance complaint management. It scans and categorizes complaints, flags critical issues, and provides actionable recommendations, significantly reducing documentation time by 90%. I’ll walk you through a hypothetical example involving an insulin delivery system, demonstrating how the agent identifies problems and suggests classifications. Please take a moment to review the findings and consider how this could improve our processes., In this video, I’m excited to show you how our Anomaly Review Agent works to enhance anomaly management. The agent scans records for completeness, flags missing evidence, and suggests updates to ensure critical anomalies are addressed promptly. I’ll walk you through its capabilities, including how it analyzes data from various systems and provides actionable recommendations. Please take a moment to review the agent's findings and consider how it can streamline your workflow. (2,453 words) - [blog/story-of-ketryx/index.html](/blog/story-of-ketryx/index.html) (1 words) - [blog/we-put-our-own-qms-under-the-microscope-heres-what-we-found.html](/blog/we-put-our-own-qms-under-the-microscope-heres-what-we-found.html) (1 words) - [blog/understanding-software-as-a-medical-device-samd/index.html](/blog/understanding-software-as-a-medical-device-samd/index.html) (1 words) - [blog/ketryx-ai-agents/index.html](/blog/ketryx-ai-agents/index.html) (1 words) - [case-studies/change-impact-ketryx-ai/index.html](/case-studies/change-impact-ketryx-ai/index.html) (1 words) - [blog/ketryx-2-9/index.html](/blog/ketryx-2-9/index.html) (1 words) - [blog/ketryx-intelligence/index.html](/blog/ketryx-intelligence/index.html) (1 words) - [gen/validated-ai-conference/index.html](/gen/validated-ai-conference/index.html) (1 words) - [Validated AI Conference — Cambridge, MA](/gen/validated-ai-conference-on-demand/index.html): , Connect with life sciences innovators and learn how to validate AI faster so you can bring life-changing technology to market sooner. (351 words) - [Oh no, you've reached a page that's been uprooted.](/blog/medical-device-software-validation-and-verification-for-regulatory-compliance.html) (72 words) - [learn/index.html](/learn/index.html) (1 words) - [blog/a-comprehensive-guide-to-iec-62304-navigating-the-standard-for-medical-device-software.html](/blog/a-comprehensive-guide-to-iec-62304-navigating-the-standard-for-medical-device-software.html) (1 words) - [New in 2.11: Enhanced Jira Traceability Widget](/videos/jira-traceability-widget-improvements/index.html): See how the enhanced Ketryx traceability widget in Jira improves the interoperability of your regulated development ecosystem. (206 words) - [Validated AI Conference Half Day](/events/validated-ai-conference-half-day-april-2026/index.html) (626 words) - [Unburdening Builders: Reinventing Regulated Development with AI](/videos/unburdening-builders-reinventing-regulated-development-with-ai.html) (138 words) - [Polarion](/integrations/polarion/index.html) (419 words) - [How Flo Transitioned from Unregulated to Regulated Development—Without Losing Speed](/case-studies/flo-health/index.html) (800 words) - [Oh no, you've reached a page that's been uprooted.](/learn/webinars/using-a-risk-based-approach-to-comply-with-fda/index.html) (72 words) - [Recalls Are Rising. Panic Doesn’t Have To.](/blog/recalls-are-rising-panic-doesnt-have-to/index.html): FDA recalls are an ongoing operational reality, and the real damage isn't the recall itself—it's how unprepared organizations are to execute quickly, risking patient safety, reputation, and regulatory standing. (869 words) - [Ketryx Enters 2026 with Record Momentum as Demand for Validated AI Surges](/press-release/momentum-as-demand-for-validated-ai-surges/index.html): $39M Series B, First Validated AI Agents, and Major Customer Wins Position Ketryx as the Compliance Platform of Choice for Life Sciences (884 words) - [Why Obsessing Over Documentation Might Be Making Your Product Less Safe](/blog/document-centric-approach/index.html): Learn how regulated teams can move from a document-centric approach to creating documentation automatically as a byproduct of development work. (971 words) - [learn/webinars/register/git-for-iec-62304-traceability-for-software-design-unit-testing-and-requirements.html](/learn/webinars/register/git-for-iec-62304-traceability-for-software-design-unit-testing-and-requirements.html) (1 words) - [Oh no, you've reached a page that's been uprooted.](/learn/webinars/register/fda-cyber-guidance-implications-for-soup-and-ots-risk-management.html) (72 words) - [case-studies/aignostics-case-study/index.html](/case-studies/aignostics-case-study/index.html) (1 words) - [Streamlining Validation with Ketryx](/videos/streamlining-validation-with-ketryx/index.html) (132 words) - [Watch how Ketryx applies AI to automate compliance in regulated software](/blog/watch-how-ketryx-applies-ai-to-automate-compliance-in-regulated-software.html): In an interview with Ketryx Head of Product Gabriel Pascualy, discover how Ketryx uses AI to embed compliance directly into development workflows, helping regulated industries eliminate manual documentation bottlenecks and accelerate audit readiness. (275 words) - [Oh no, you've reached a page that's been uprooted.](/learn/webinars/register/git-for-iec-62304-2024-10-31/index.html) (72 words) - [Oh no, you've reached a page that's been uprooted.](/learn/webinars/register/transitioning-from-monolithic-to-microservices-how-to-adopt-a-systems-of-systems-approach-for_your_sdlc.html) (72 words) - [Navigating ISO 26262 and IEC 61508-3 Functional Safety Standards for Safety-Critical Software](/blog/navigating-iso-26262-and-iec-61508-3-functional-safety-standards.html): Learn how ISO 26262 and IEC 61508-3 govern safety-critical software development, from hazard analysis to traceability requirements. Discover common pitfalls and practical strategies to build compliance into your engineering process from the start. (3,753 words) - [Oh no, you've reached a page that's been uprooted.](/learn/webinars/register/postmarket-surveillance-of-ai-systems-proactive-methods-for-identifying-risk-and-improving-product-quality.html) (72 words) - [Oh no, you've reached a page that's been uprooted.](/learn/webinars/register/making-jira-fit-for-62304-developing-fda-compliant-software.html) (72 words) - [Oh no, you've reached a page that's been uprooted.](/learn/webinars/register/why-building-ai-ml-enabled-medical-devices-requires-ci-cd-a-transition-path.html) (72 words) - [Ketryx raises $14M in Series A funding led by Lightspeed Venture Partners](/press-release/ketryx-raises-14m-in-series-a-funding-led-by-lightspeed-venture-partners.html): Investment fuels innovation to ensure patient safety and validate the use of AI in medical devices (745 words) - [Ketryx for Medical Devices](/industries/medical-devices/index.html): Automate documentation and compliance for life science teams. Real-time traceability, AI-powered change impact assessment, Git-integrated workflows, automatic documentation, and market-ready outputs. (997 words) - [Anomaly Scoping Agents](/videos/anomaly-scoping-agents/index.html) (131 words) - [Jira](/integrations/jira/index.html) (424 words) - [How Cytovale Transformed Change Impact Assessment with Ketryx AI](/case-studies/how-cytovale-transformed-change-impact-assessment-ketryx-ai.html) (793 words) - [Ketryx AI Change Impact Assessment](/videos/assistant-change-impact-assessment/index.html) (133 words) - [New in 2.11: RTM Configurations](/videos/predefined-rtm-configurations/index.html): Improve traceability with Ketryx's predefined requirements traceability matrix configurations. (179 words) - [Ketryx Appoints Mary Brook Delano as Chief Business Officer to Accelerate Growth, Sales Execution, and Customer Impact](/press-release/ketryx-appoints-mary-brook-delano-as-chief-business-officer-to-accelerate-growth-sales-execution-and-customer-impact.html): Seasoned commercial leader joins to supercharge company's sales engine (498 words) - [Tracing Manual and Automated Tests across Jira and Connected Systems](/videos/tracing-manual-and-automated-tests-across-jira-and-connected-systems.html) (138 words) - [contact-us/index.html](/contact-us/index.html) (1 words) - [Optimizing a Regression Testing Agent](/videos/optimizing-a-regression-testing-agent/index.html) (133 words) - [How to Validate Ketryx](/blog/how-to-validate-ketryx/index.html): Learn how Ketryx validates its platform for medical device software companies, and get expert guidance on which validation strategy your organization should pursue. (2,211 words) - [Asking a Compliance Question with Ketryx MCP](/videos/asking-a-compliance-question-with-ketryx-mcp/index.html) (138 words) - [Why The Epidemic In Quality Failures And What MedTechs Can Learn](/blog/why-the-epidemic-in-quality-failures-and-what-medtechs-can-learn.html): Explore how outdated systems, manual processes, and increasing complexity contribute to rising quality failures in safety-critical industries. Learn how automation and AI can revolutionize quality management, ensuring safety, efficiency, and innovation. (544 words) - [Introduction to Ketryx](/videos/ketryx-demo-video/index.html) (214 words) - [Validated — San Diego Life Sciences Networking](/gen/ai-san-diego-meetup/index.html): Join us in San Diego during the MedTech Conference as Ketryx brings medtech leaders together for cocktails, appetizers, and real-world conversations about how teams are moving beyond outdated workflows and introducing AI into their products and processes. Hear from experts, connect with peers, and be part of a community working to bring safe, effective AI to life sciences., Connect with life sciences innovators and learn how to validate AI faster so you can bring life-changing technology to patients sooner. (376 words) - [Ketryx Unveils the First Connected Lifecycle Software for MedTechs](/press-release/ketryx-unveils-the-first-connected-lifecycle-software-for-medtechs.html): Bringing FDA-approved, life-saving innovations to patients 3x faster (487 words) - [End-to-End Coding Agents](/videos/end-to-end-coding-agents/index.html) (134 words) - [Boston RAPS Chapter In Person Event: Navigating Evolving Global Requirements to Strengthen Regulatory Readiness Worldwide](/events/boston-raps-networking/index.html) (256 words) - [Navigating the FDA’s Total Product Lifecycle Framework for Generative AI Devices](/learn/webinars/register/navigating-the-fdas-total-product-lifecycle-framework-for-generative-ai-devices-2.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (241 words) - [A Guide To Implementing CI/CD in Your AI/ML SaMD Projects](/assets/ci-cd-ai-ml-white-paper/index.html): The number of AI-powered medical devices is rapidly increasing, with 950 AI/ML-enabled devices already authorized by the FDA. However, the journey to successfully developing and managing these complex systems remains challenging for many manufacturers. Continuous Integration/Continuous Deployment (CI/CD) is now essential for enabling AI/ML in medical software. Medical software teams can align this practice with FDA guidance to ensure product safety while accelerating development timelines. (167 words) - [Inside the FDA Regulatory Process](/white-papers/inside-the-fda-regulatory-process/index.html): Former FDA software systems safety expert, Paul Jones, shares his insights. (319 words) - [Product Spotlight Webinar - Google Drive as a Governed Part of Your eQMS](/learn/webinars/register/product-spotlight-webinar-google-drive-as-a-governed-part-of-your-eqms.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (264 words) - [Ketryx Launches Validated AI Conference, a First-of-Its-Kind Industry Event for AI in Regulated Industries](/press-release/ketryx-launches-validated-ai-conference-a-first-of-its-kind-industry-event-for-ai-in-regulated-industries.html): Event Brings Together Engineering, Quality, and Regulatory Leaders Tackling the AI Compliance Challenge in MedTech and Life Sciences (506 words) - [FDA Predetermined Change Control Plan (PCCP) Template](/assets/pccp-template/index.html): This template is designed to assist organizations in developing a comprehensive plan to manage and assess modifications to Machine Learning Device Software Functions (ML-DSFs) in medical devices. The Predetermined Change Control Plan (PCCP) is a document that outlines the planned changes to the device, the methods for evaluating these changes, and the impact assessment to ensure the continued safety and effectiveness of the device. (566 words) - [Product Spotlight Webinar - Google Drive as a Governed Part of Your eQMS](/learn/webinars/on-demand/product-spotlight-webinar-google-drive-integration-feb-26.html) (223 words) - [How to Use AI Agents in Safety-Critical Industries](/learn/webinars/register/how-to-use-ai-agents-in-safety-critical-industries/index.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (256 words) - [IEC 62304 Compliance Checklist](/assets/iec-62304-compliance-checklist/index.html): Companies can take a few key steps to evaluate quality practices on their FDA compliance journey to build medical software. Use this checklist to manage the key steps. (146 words) - [Ketryx Announces DeepHealth Selected Its Software to Accelerate AI-Powered Health Informatics Innovation](/press-release/ketryx-announces-deephealth-selected-its-software-to-accelerate-ai-powered-health-informatics-innovation.html) (653 words) - [Implementing a PCCP & CI/CD for AI/ML-Enabled Medical Devices](/learn/webinars/on-demand/implementing-a-pccp-ci-cd-for-ai-ml-enabled-medical-devices.html) (310 words) - [Ketryx Assistant](/capabilities/ketryx-assistant/index.html): Build with FDA compliance and ALM software 3x faster with Ketryx Compliance Framework. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (709 words) - [Scaling AI Responsibly for MedTech and Life Sciences with Validated AI](/videos/scaling-ai-responsibly-firesidechat/index.html) (142 words) - [Part 11-Compliant Audit Trail in Jira with Ketryx](/videos/part-11-compliant-audit-trail-video/index.html) (204 words) - [Health ISAC Spring Americas Summit](/events/health-isac-spring-americas-summit/index.html) (82 words) - [Ketryx Announces DeepHealth Selected Its Software to Accelerate AI-Powered Health Informatics Innovation](/case-studies/deephealth-case-study/index.html) (716 words) - [Agent Pull Requests](/videos/agent-pull-requests/index.html) (134 words) - [Prosthetics & Robtoics](/events/prosthetics-robtoics/index.html) (80 words) - [Claude Code](/integrations/claude/index.html) (336 words) - [Solving the Agile Dilemma: Speed and Safety for AI/ML-Enabled Medical Devices](/learn/webinars/register/the-agile-advantage-speed-and-safety-for-ai-ml-enabled-medical-devices.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (281 words) - [MEDevice Boston](/events/medevice-boston/index.html) (79 words) - [Connecting SBOM Vulnerabilities to Safety Risk](/videos/connecting-sbom-vulnerabilities-to-safety-risk/index.html) (93 words) - [Three steps for traceability in medical device software development quality and compliance](/blog/three-steps-for-traceability-in-medical-device-software-development-quality-and-compliance.html): When reviewing the software in software-as-a-medical-device (SaMD), software-in-medical-devices (SiMD) and systems-of-systems-of-medical-devices (SosMD) at the FDA, I was always looking for sufficient evidence to justify the sponsor’s claim that the device performs as intended — safely and effectively. (420 words) - [QMS Optimization Workshop Template](/assets/qms-optimization-workshop-template/index.html): This practical workshop template is designed to guide regulated teams in regular QMS reviews to identify process debt and apply a modern, risk-based, AI-assisted approach to quality processes. (148 words) - [Copilot](/integrations/copilot/index.html) (281 words) - [How Heartflow Reduced Complexity by 90% in 10 Weeks with a System of Systems](/case-studies/heartflow-case-study/index.html) (770 words) - [FDA PCCP Compliance Guide](/white-papers/fda-pccp-compliance-guide/index.html): Learn more about the FDA's guidance on PCCPs (Predetermined Change Control Plans) for AI/ML-enabled medical device software. (422 words) - [How Flo Is Building Regulatory Readiness, Fast](/learn/webinars/register/rerun-how-flo-is-building-regulatory-readiness-fast.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (323 words) - [Item Variant Management: Baseline Locking](/videos/item-variant-management-baseline-locking/index.html) (138 words) - [How This AI-Powered Medical Software Company Reduced SBOM Documentation Time by 90%](/case-studies/nutrino-case-study/index.html) (514 words) - [Answering Compliance Questions using Cursor](/videos/answering-compliance-questions-using-cursor/index.html) (136 words) - [How Meta Reality Labs Accelerates Product Innovation with AI](/case-studies/how-meta-reality-labs-accelerates-safe-innovation-with-ai.html) (522 words) - [Checking Software Complies with a Specific Standard with Ketryx Assistant](/videos/checking-software-complies-with-a-specific-standard-with-ketryx-assistant.html) (141 words) - [How to Conduct a Change Impact Assessment with Ketryx Assistant](/videos/how-to-conduct-a-change-impact-assessment-with-ketryx-assistant.html) (106 words) - [Using a risk-based approach to comply with 21 CFR Part 11](/learn/webinars/on-demand/using-a-risk-based-approach-to-comply-with-21-cfr-part-11.html) (138 words) - [Ketryx Intelligence](/videos/ketryx-intelligence/index.html) (159 words) - [Jira for regulated development: Making Jira fit for IEC 62304](/learn/webinars/on-demand/jira-for-regulated-development-making-jira-fit-for-iec-62304.html) (145 words) - [Jira for IEC 62304: Developing FDA-Compliant Software](/learn/webinars/on-demand/jira-for-62304-jan-26/index.html) (221 words) - [SonarQube](/integrations/sonarqube/index.html) (77 words) - [Life Sciences AI on Tap: Connect with Boston’s Life Sciences Community](/events/life-sciences-ai-march/index.html) (195 words) - [ADO to Polarion Traceability](/videos/ado-polarion-traceability/index.html) (132 words) - [Jira for 62304: July 31, 2025](/learn/webinars/on-demand/jira-for-62304-july-2025/index.html) (152 words) - [SaMD Regulatory Requirements](/assets/samd-regulatory-requirements/index.html): Learn which essential regulations and standards are necessary to meet compliance for SaMD and other medical device software. (141 words) - [Jira for IEC 62304: Developing FDA-compliant software](/learn/webinars/on-demand/jira-for-iec-62304-developing-fda-compliant-software.html) (109 words) - [Ketryx Announces Beta of Model Context Protocol (MCP) to Bring Compliance Intelligence into AI Workflows](/press-release/ketryx-announces-mcp/index.html): Launch enables regulated development teams to use agents with full compliance awareness from AI tools like ChatGPT, Claude, and Copilot (652 words) - [How Vektor Medical Accelerated Documentation Time by Over 60% with Ketryx](/case-studies/vektor-medical-case-study/index.html) (565 words) - [Paving the Way for Continuous Innovation: Navigating FDA PCCP Authorization for AI-Driven Medical Devices](/learn/webinars/register/paving-the-way-for-continuous-innovation-navigating-fda-pccp-authorization-for-ai-driven-medical-devices.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (259 words) - [SBOM and Beyond: FDA-Compliant Cybersecurity Vulnerability Management](/learn/webinars/on-demand/sbom-and-beyond-fda-compliant-cybersecurity-vulnerability-management.html) (250 words) - [Jira Data Center](/integrations/jira-data-center/index.html) (428 words) - [Checking for Missing Traceability Links for Test Coverage with Ketryx MCP](/videos/checking-for-missing-traceability-links-for-test-coverage-with-ketryx-mcp.html) (139 words) - [The VentureFizz Podcast with Erez Kaminski](/blog/the-venturefizz-podcast-with-erez-kaminski/index.html): As I’ve covered in multiple episodes of The VentureFizz Podcast, all industries are ripe for disruption with AI, especially life sciences. However, life sciences is difficult because it is heavily regulated which makes it challenging for people to build a startup without that industry knowledge. (331 words) - [Ketryx Raises $14 Million to Boost Software Safety in Healthcare](/blog/ketryx-raises-14-million-to-boost-software-safety-in-healthcare.html): Ketryx raises $14M in Series A funding led by Lightspeed Venture Partners to accelerate product development, enhance medical software safety, and streamline regulatory compliance for healthcare applications. (272 words) - [How Foresight Diagnostics Reduced Documentation Time by 80%](/case-studies/foresight-diagnostics-case-study/index.html) (577 words) - [Streamlining Multi-Region Submissions: MDR, FDA, and EU AI Act](/learn/webinars/register/streamlining-multi-region-submissions-with-raps/index.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (418 words) - [International MedTech Safety Conference](/events/international-medtech-safety-conference/index.html) (81 words) - [ADO for IEC 62304 and AI: Developing FDA-Compliant Software in Azure DevOps](/learn/webinars/on-demand/ado-for-iec-62304-and-ai-developing-fda-compliant-software-in-azure-devops-un-gated.html) (199 words) - [How to Validate AI-Enabled, Non-Product Software, Fast](/learn/webinars/register/how-to-validate-ai-enabled-non-product-software/index.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (324 words) - [Responding to FDA Feedback with Ketryx AI](/videos/responding-to-fda-feedback-with-ketryx-ai/index.html) (138 words) - [AI + Expo](/events/ai-expo/index.html) (80 words) - [MIT Media Lab Spring Meeting 2022: E14 Startups](/blog/mit-media-lab-spring-meeting-2022-e14-startups/index.html): During the 2022 Spring Meeting, many startups affiliated with the Media Lab will be presenting (hosted by the E14 Fund). Learn what startups will be there. (247 words) - [New FDA SOUP/OTS Guidance: Managing Risk and Testing at Scale](/learn/webinars/on-demand/new-fda-soup-ots-guidance-managing-risk-and-testing-at-scale.html) (189 words) - [How Meta Preserves a Best-in-Class Engineering Culture in a Regulated Environment](/learn/webinars/register/how-meta-preserves-a-best-in-class-engineering-culture-in-a-regulated-environment.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (288 words) - [How a Fortune 50 Company Assessed Vulnerabilities 80% Faster](/case-studies/assess-vulnerabilities-faster/index.html) (505 words) - [Medical Device Software Development Summit](/events/medical-device-software-development-summit/index.html) (82 words) - [From AI Curious to AI Native: Top Use Cases For AI Across Regulated SDLCs](/learn/webinars/on-demand/from-ai-curious-to-ai-native-top-use-cases-for-ai-across-regulated-sdlcs.html) (260 words) - [Ketryx raises $14m in Series A funding](/blog/ketryx-raises-14m-in-series-a-funding/index.html): Ketryx raises $14M in Series A funding to expand its Connected Lifecycle Management platform, enabling faster, safer software development for the life sciences industry while maintaining FDA compliance. (343 words) - [How Meta Preserves a Best-in-Class Engineering Culture in a Regulated Environment](/learn/webinars/on-demand/how-meta-preserves-a-best-in-class-engineering-culture-in-a-regulated-environment.html) (238 words) - [UL Certification: A Launchpad for Product Development Excellence](/blog/ul-certification-a-launchpad-for-product-development-excellence.html): Early in my company’s short history, I almost made a big mistake by passing on getting UL Certification. My team, however, made a compelling case to move forward with what ended up being a core driver of our success to date in attracting new customers and partners. (556 words) - [How to Build Safer and More Reliable Software](/blog/how-to-build-safer-and-more-reliable-software/index.html): Innovative software continues to disrupt society as we know it, including solving big problems, squeezing out new efficiencies and creating a better quality of life. (406 words) - [How To Check Completed Work Aligned with Your QMS with Ketryx Assistant](/videos/how-to-check-completed-work-aligned-with-your-qms-with-ketryx-assistant.html) (105 words) - [Jira for IEC 62304: Developing FDA-Compliant Software](/learn/webinars/register/jira-for-iec-62304-jan-25/index.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (269 words) - [Git for IEC 62304: Traceability for Software Design, Unit Testing & Requirements](/learn/webinars/on-demand/git-for-iec-62304-traceability-for-software-design-unit-testing-requirements.html) (214 words) - [sitemap-xml.html](/sitemap-xml.html) (398 words) - [Jira for IEC 61508: Functional Safety Where Robotics & Physical AI Teams Already Work](/learn/webinars/on-demand/jira-for-iec-61508/index.html) (310 words) - [Product Spotlight Webinar: AI-Native Development & Compliance with Ketryx MCP](/learn/webinars/on-demand/product-spotlight-webinar-ai-native-development-compliance-with-ketryx-mcp.html) (235 words) - [Cucumber](/integrations/cucumber/index.html) (77 words) - [Jira for IEC 62304: Developing FDA-Compliant Software](/learn/webinars/on-demand/jira-for-iec-62304-2024-10-03/index.html) (153 words) - [Jira for IEC 62304: Developing FDA-Compliant Software](/learn/webinars/register/jira-for-iec-62304-may-26/index.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (250 words) - [Why Resubmit When You Can Ship? How to Accelerate Innovation with PCCPs and CI/CD](/learn/webinars/on-demand/why-resubmit-when-you-can-ship-how-to-accelerate-innovation-with-pccps-and-ci-cd.html) (277 words) - [Empowering the SDLC Process with Tools to Bridge R&D and Quality](/learn/webinars/register/empowering-sdlc-process-tools-bridge-rd-quality/index.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (399 words) - [How Oui Therapeutics Unified and Accelerated Their SDLC](/case-studies/oui-therapeutics/index.html) (401 words) - [Simplifying 62304 and AI Compliance with Jira & Polarion](/learn/webinars/on-demand/simplifying-62304-and-ai-compliance-with-jira-polarion.html) (196 words) - [Top of the Morning](/blog/top-of-the-morning/index.html): Bosted based start-up and provider of lifecycle management software for life sciences raised $14m in Series A Funding (138 words) - [Enforcement in Jira with Ketryx](/videos/enforcement-in-jira-with-ketryx-video/index.html) (120 words) - [Validated AI Conference](/events/validated-ai-conference/index.html) (213 words) - [The Cost of Quality](/assets/the-cost-of-quality/index.html): Quality is the ability of a product to meet its requirements and customer expectations without issue. It’s the foundation of any product, from its development to its introduction to consumers. Without it, businesses waste resources and labor, lose time, jeopardize sales and market share, and risk financial penalties. This whitepaper will dive into how to reduce CoQ through improved software development infrastructure, explore 10 ways to meet key quality controls, and go through a three-step action plan for regulated software developers. (148 words) - [A Playbook for Transforming Jira to Support IEC 62304 Compliance](/assets/a-playbook-for-transforming-jira-to-support-iec-62304-compliance.html): To bridge the gap between Jira’s capabilities and IEC 62304 requirements, Ketryx offers integration that extends Jira’s functionality to support compliance. Learn how Ketryx transforms Jira into a powerful tool for IEC 62304-compliant software development. (166 words) - [Performing a Release in Ketryx](/videos/release-in-ketryx-video/index.html) (194 words) - [FDA-Grade AI: Total Product Lifecycle Control with a PCCP](/learn/webinars/on-demand/fda-grade-ai-total-product-lifecycle-control-with-a-pccp.html) (181 words) - [SaMD Regulatory Requirements](/white-papers/samd-regulatory-requirements/index.html): Learn which regulations and standards are necessary to meet compliance for Software as a Medical Device. (279 words) - [Ketryx AI-Assisted Impact Assessment Workflow](/impact-assessment-workflow/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (127 words) - [Zapier](/integrations/zapier/index.html) (77 words) - [The Future of Change Management for Cloud-Based AI/ML Medical Software](/learn/webinars/on-demand/the-future-of-change-management-for-cloud-based-ai-ml-medical-software.html) (133 words) - [Local Traceability in Jira with Ketryx](/videos/local-traceability-in-jira-with-ketryx/index.html) (182 words) - [Understanding Release Readiness with Ketryx MCP](/videos/understanding-release-readiness-with-ketryx-mcp/index.html) (137 words) - [Managing Requirements with Jira and Ketryx](/videos/managing-requirements-jira-ketryx/index.html) (141 words) - [Ketryx to ADO Live Traceability Integration](/videos/ketryx-ado-to-live-traceability-integration/index.html) (107 words) - [IDC Spotlight: Connected Life-Cycle Management Streamlines Software Development for Medical Devices](/assets/idc-clm-spotlight-paper/index.html): This IDC Spotlight paper examines the challenges of managing medical device software development under strict regulatory requirements. It introduces Connected Life-Cycle Management (CLM) as the next-generation approach, offering a superior alternative to traditional PLM and ALM by integrating compliance into modern workflows, improving traceability, and enabling faster, more efficient software updates. (146 words) - [Ketryx raises $39M to advance AI compliance in life sciences](/blog/ketryx-raises-39m-to-advance-ai-compliance-in-life-sciences.html): AI-native compliance infrastructure, trusted by top Life Science and Fortune 500 firms, secures funding led by Transformation Capital. (223 words) - [Transitioning to FDA’s New Premarket Submission Guidance](/learn/webinars/on-demand/transitioning-to-fdas-new-premarket-submission-guidance.html) (133 words) - [Risk Management in Jira and Ketryx](/videos/risk-management-in-jira-and-ketryx/index.html) (111 words) - [Regulatory Pathways](/assets/regulatory-pathways/index.html): Learn about the different approval pathways possible, and how to find the one that works best for you. (137 words) - [Understanding the FDA's New Draft Guidance on AI-Enabled Devices: What MedTech Companies Need to Know](/learn/webinars/register/understanding-the-fdas-new-draft-guidance-on-ai-enabled-devices-what-medtech-companies-need-to-know.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (263 words) - [Ketryx raises $39 million in Series B funding to expand AI compliance tools for life sciences](/blog/ketryx-raises-39-million-in-series-b-funding-to-expand-ai-compliance-tools-for-life-sciences.html): Cambridge, Massachusetts–based Ketryx, a software platform company that automates regulatory compliance for medical device and life sciences companies, has secured $39 million in Series B funding led by Transformation Capital, pushing its total raised to more than $55 million. (242 words) - [Paving the Way for Continuous Innovation: Navigating FDA PCCP Authorization for AI-Driven Medical Devices with Beacon Biosignals](/learn/webinars/on-demand/paving-the-way-for-continuous-innovation-navigating-fda-pccp-authorization-for-ai-driven-medical-devices-with-beacon-biosignals.html) (184 words) - [FDA PCCP Compliance Guide](/assets/fda-pccp-compliance-guide/index.html): The FDA's guidance on Predetermined Change Control Plans (PCCPs) aims to streamline regulatory processes for AI/ML-enabled medical devices. The guidance allows manufacturers to make software updates without requiring new premarket submissions, fostering innovation while maintaining safety and effectiveness. (148 words) - [Part 11-Compliant Signatures in Jira](/videos/part-11-compliant-signatures-in-jira/index.html) (116 words) - [MedCon Conference](/events/medcon-conference/index.html) (79 words) - [The MedTech Conference - Advamed](/events/the-medtech-conference/index.html) (82 words) - [Ketryx raises $39m to advance AI compliance platform](/blog/ketryx-raises-39m-to-advance-ai-compliance-platform.html): Ketryx plans to use the funds to fuel the ongoing development of the AI compliance-related tools its medtech clients are requesting. (179 words) - [Why Resubmit When You Can Ship? How to Accelerate Innovation with PCCPs and CI/CD](/learn/webinars/register/why-resubmit-when-you-can-ship-how-to-accelerate-innovation-with-pccps-and-ci-cd.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (422 words) - [FDA Cyber Guidance and the Software Supply Chain - A Playbook for Shifting Left](/assets/fda-cyber-guidance-and-the-software-supply-chain-a-playbook-for-shifting-left.html): Learn how to navigate the complex landscape of cybersecurity for medical devices with this comprehensive guide. This white paper outlines actionable strategies to address vulnerabilities, manage risks, and meet FDA cybersecurity requirements throughout the product lifecycle. Learn how to shift left with integrated tools and processes, enabling faster responses to emerging threats while ensuring compliance and protecting patient safety. 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(265 words) - [Streamlining Multi-Region Submissions: MDR, FDA, and EU AI Act](/learn/webinars/on-demand/streamlining-multi-region-submissions-mdr-fda-and-eu-ai-act-with-raps.html) (364 words) - [European Medical Device Summit](/events/european-medical-device-summit/index.html) (81 words) - [Discover Why Traceability Doesn't Have to Be So Hard](/assets/discover-why-traceability-doesnt-have-to-be-so-hard.html): Software is the leading cause of medical device recalls. Heavily regulated products such as safety-critical medical devices require that every step of the development process must be traceable with a rigorous process designed to identify potential risk factors and their contributing conditions. (162 words) - [How Flo Is Building Regulatory Readiness for Its AI-Enabled Digital Health App, Fast](/learn/webinars/register/how-flo-is-building-regulatory-readiness-for-its-ai-enabled-digital-health-app-fast.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (308 words) - [Validating AI & LLMs in GxP Use Cases](/learn/webinars/register/validating-ai-llms-in-gxp-use-cases/index.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (261 words) - [Git for IEC 62304: Traceability for software design, unit testing, and requirements](/learn/webinars/on-demand/git-for-iec-62304-traceability-for-software-design-unit-testing-and-requirements.html) (294 words) - [Device Talks Boston | Robotics Summit](/events/device-talks-boston-robotics-summit/index.html) (83 words) - [Implementing a PCCP & CI/CD for AI/ML-Enabled Medical Devices](/learn/webinars/register/implementing-a-pccp-ci-cd-for-ai-ml-enabled-medical-devices.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (341 words) - [Breaking the Change Impact Assessment Bottleneck with AI](/learn/webinars/on-demand/breaking-the-change-impact-assessment-bottleneck-with-ai.html) (216 words) - [The Future of Change Management for Cloud-based AI/ML Medical Software](/learn/webinars/register/the-future-of-change-management-for-cloud-based-ai-ml-medical-software.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (337 words) - [How Flo Is Building Regulatory Readiness, Fast](/learn/webinars/on-demand/how-flo-is-building-regulatory-readiness-fast/index.html) (233 words) - [Solving the Agile Dilemma: Speed and Safety for AI/ML-Enabled Medical Devices](/learn/webinars/on-demand/solving-the-agile-dilemma-speed-and-safety-for-ai-ml-enabled-medical-devices.html) (232 words) - [Understanding the FDA's New Draft Guidance on AI-Enabled Devices](/learn/webinars/on-demand/understanding-the-fdas-new-draft-guidance-on-ai-enabled-devices.html) (208 words) - [Lessons learned from 23 MedTech companies in 2024](/videos/lessons-learned-from-23-medtech-companies-in-2024/index.html) (139 words) - [SPDX](/integrations/spdx/index.html) (77 words) - [Git for IEC 62304: Traceability for Software Design, Unit Testing & Requirements](/learn/webinars/on-demand/git-for-62304-jan-26/index.html) (236 words) - [Jira for IEC 62304 Continued](/learn/webinars/on-demand/jira-for-iec-62304-continued/index.html) (136 words) - [Jira for IEC 62304: Developing FDA-Compliant Software](/learn/webinars/on-demand/re-broadcast-jira-for-iec-62304-developing-fda-compliant-software.html) (142 words) - [blog/why-so-many-medical-device-companies-lack-real-time-traceability-and-visibility.html](/blog/why-so-many-medical-device-companies-lack-real-time-traceability-and-visibility.html) (1 words) - [blog/ketryx-2-11/index.html](/blog/ketryx-2-11/index.html) (1 words) - [Jira for IEC 61508: Functional Safety Where Robotics & Physical AI Teams Already Work](/learn/webinars/register/jira-for-iec-61508-march-2026/index.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (366 words) - [blog/fda-drops-an-sbom/index.html](/blog/fda-drops-an-sbom/index.html) (1 words) - [about/company/index.html](/about/company/index.html) (1 words) - [press-release/ketryx-marks-milestone-year-impacting-over-20m-patients-in-medtech.html](/press-release/ketryx-marks-milestone-year-impacting-over-20m-patients-in-medtech.html) (1 words) - [blog/fda-software-verification-vs-validation-whats-the-difference.html](/blog/fda-software-verification-vs-validation-whats-the-difference.html) (1 words) - [blog/ado-integration/index.html](/blog/ado-integration/index.html) (1 words) - [blog/process-and-tooling/index.html](/blog/process-and-tooling/index.html) (1 words) - [blog/the-fda-just-published-free-advice-for-building-with-ai.html](/blog/the-fda-just-published-free-advice-for-building-with-ai.html) (1 words) - [capabilities/professional-services/index.html](/capabilities/professional-services/index.html) (1 words) - [learn/events/index.html](/learn/events/index.html) (1 words) - [blog/building-fda-compliant-sboms-for-medtech/index.html](/blog/building-fda-compliant-sboms-for-medtech/index.html) (1 words) - [blog/medtech-compliance-not-regulation-is-stifling-innovation.html](/blog/medtech-compliance-not-regulation-is-stifling-innovation.html) (1 words) - [blog/iso-14971-a-comprehensive-guide-to-risk-management-in-medical-devices.html](/blog/iso-14971-a-comprehensive-guide-to-risk-management-in-medical-devices.html) (1 words) - [blog/how-ketryx-works-product-design-philosophy-and-framework.html](/blog/how-ketryx-works-product-design-philosophy-and-framework.html) (1 words) - [industries/robotics/index.html](/industries/robotics/index.html) (1 words) - [blog/ketryx-2-6/index.html](/blog/ketryx-2-6/index.html) (1 words) - [blog/how-medtechs-can-retain-developers/index.html](/blog/how-medtechs-can-retain-developers/index.html) (1 words) - [blog/building-the-infrastructure-for-regulated-ai-announcing-ketryx-39m-series-b.html](/blog/building-the-infrastructure-for-regulated-ai-announcing-ketryx-39m-series-b.html) (1 words) - [blog/patch-act-how-to-comply-in-2023-beyond/index.html](/blog/patch-act-how-to-comply-in-2023-beyond/index.html) (1 words) - [about/newsroom/index.html](/about/newsroom/index.html) (1 words) - [blog/the-best-rtm-tools-for-agile-teams-looking-beyond-excel.html](/blog/the-best-rtm-tools-for-agile-teams-looking-beyond-excel.html) (1 words) - [blog/best-practices-for-maintaining-a-requirement-traceability-matrix-in-agile.html](/blog/best-practices-for-maintaining-a-requirement-traceability-matrix-in-agile.html) (1 words) - [industries/defense/index.html](/industries/defense/index.html) (1 words) - [blog/implementing-pccp-ci-cd-for-ai-ml-enabled-medical-devices-a-comprehensive-guide.html](/blog/implementing-pccp-ci-cd-for-ai-ml-enabled-medical-devices-a-comprehensive-guide.html) (1 words) - [capabilities/eqms/index.html](/capabilities/eqms/index.html) (1 words) - [partnerships/index.html](/partnerships/index.html) (1 words) - [learn/white-papers/index.html](/learn/white-papers/index.html) (1 words) - [blog/fda-class-ii-medical-device-regulations-and-compliance.html](/blog/fda-class-ii-medical-device-regulations-and-compliance.html) (1 words) - [blog/how-to-create-a-design-history-file-dhf-for-medical-devices.html](/blog/how-to-create-a-design-history-file-dhf-for-medical-devices.html) (1 words) - [blog/fda-class-i-medical-device-regulations-and-compliance.html](/blog/fda-class-i-medical-device-regulations-and-compliance.html) (1 words) - [IEC 62304 & Requirements Traceability Matrix (RTM) in Jira: A Guide for Medical Device Companies](/blog/iec-62304-requirements-traceability-matrix-rtm-in-jira-a-guide-for-medical-device-companies.html): IEC 62304 defines the software development lifecycle (SDLC) processes for medical device software. With traceability as a main component of this standard, the challenge companies often face is how to use preferred development tools like Jira for SDLC management that are not built to provide the level of traceability required by 62304 and the FDA. This guide will focus on how companies can meet IEC 62304 and generate a compliant Requirements Traceability Matrix (RTM) while using Jira. (1,628 words) - [capabilities/documentation/index.html](/capabilities/documentation/index.html) (1 words) - [blog/how-regulated-teams-release-every-two-weeks/index.html](/blog/how-regulated-teams-release-every-two-weeks/index.html) (1 words) - [blog/how-connected-lifecycle-management-is-revolutionizing-medtech-software-development.html](/blog/how-connected-lifecycle-management-is-revolutionizing-medtech-software-development.html) (1 words) - [blog/ketryx-2-0-release/index.html](/blog/ketryx-2-0-release/index.html) (1 words) - [blog/navigating-the-fdas-new-draft-guidance-on-ai-enabled-devices.html](/blog/navigating-the-fdas-new-draft-guidance-on-ai-enabled-devices.html) (1 words) - [blog/traceability-101/index.html](/blog/traceability-101/index.html) (1 words) - [blog/the-ultimate-guide-to-requirements-traceability-matrix-rtm.html](/blog/the-ultimate-guide-to-requirements-traceability-matrix-rtm.html) (1 words) - [eu-ai-act/index.html](/eu-ai-act/index.html) (1 words) - [blog/how-to-generate-an-sbom-software-bill-of-materials-fast.html](/blog/how-to-generate-an-sbom-software-bill-of-materials-fast.html) (1 words) - [capabilities/sbom-software-bill-of-materials/index.html](/capabilities/sbom-software-bill-of-materials/index.html) (1 words) - [product/index.html](/product/index.html) (1 words) - [blog/inside-ketryxs-customer-validation-package/index.html](/blog/inside-ketryxs-customer-validation-package/index.html) (1 words) - [blog/from-spreadsheets-to-system-level-clarity-how-medical-device-manufacturers-are-transforming-cybersecurity-threat-modeling.html](/blog/from-spreadsheets-to-system-level-clarity-how-medical-device-manufacturers-are-transforming-cybersecurity-threat-modeling.html) (1 words) - [blog/ai-agents-quality-impact/index.html](/blog/ai-agents-quality-impact/index.html) (1 words) - [industries/aerospace/index.html](/industries/aerospace/index.html) (1 words) - [blog/2023-fda-warning-letters-and-software-validation/index.html](/blog/2023-fda-warning-letters-and-software-validation/index.html) (1 words) - [learn/videos/index.html](/learn/videos/index.html) (1 words) - [blog/modernizing-the-medical-device-factory-to-work-with-software.html](/blog/modernizing-the-medical-device-factory-to-work-with-software.html) (1 words) - [blog/a-complete-guide-to-the-fdas-ai-ml-guidance-for-medical-devices.html](/blog/a-complete-guide-to-the-fdas-ai-ml-guidance-for-medical-devices.html) (1 words) - [Validating AI & LLMs in GxP Use Cases](/learn/webinars/on-demand/validating-ai-llms-in-gxp-use-cases/index.html) (169 words) - [use-case/hw-sw-applications/index.html](/use-case/hw-sw-applications/index.html) (1 words) - [blog/21-cfr-part-11-compliance-guide-for-jira-atlassian/index.html](/blog/21-cfr-part-11-compliance-guide-for-jira-atlassian/index.html) (1 words) - [blog/clinical-trial-computerized-systems-regulation-review.html](/blog/clinical-trial-computerized-systems-regulation-review.html) (1 words) - [Plans and Pricing](/pricing-2026/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (1,222 words) - [Simplifying 62304 and AI Compliance with Jira & Polarion](/learn/webinars/register/simplifying-62304-and-ai-compliance-with-jira-polarion.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (236 words) - [One validated platform, total compliance.](/industries/pharma-and-biotech/index.html): Automate documentation and compliance for life science teams. Real-time traceability, AI-powered change impact assessment, Git-integrated workflows, automatic documentation, and market-ready outputs. (1,084 words) - [Navigating the FDA’s Total Product Lifecycle Framework for Generative AI Devices](/learn/webinars/register/navigating-the-fdas-total-product-lifecycle-framework-for-generative-ai-devices.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (245 words) - [Transitioning from Monolithic to Microservices: How to Adopt a Systems of Systems Approach for Your SDLC](/learn/webinars/register/transitioning-from-monolithic-to-microservices-how-to-adopt-a-systems-of-systems-approach-for-your-sdlc.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (332 words) - [Ketryx 2.7](/blog/ketryx-2-7/index.html): Ketryx 2.7 introduces a new set of features that let you keep working in the tools you already use while Ketryx automatically manages traceability across the entire SDLC. With this latest release, software development teams take another step toward validated CI/CD through more connections to systems, better cybersecurity automation, and a deeper integration with Git and other common developer tools. (782 words) - [Developer-first tooling for regulated software](/function/developer/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (773 words) - [SBOM & Beyond](/learn/webinars/on-demand/sbom-beyond/index.html) (151 words) - [blog/the-turtle-problem/index.html](/blog/the-turtle-problem/index.html) (1 words) - [New Integrations with Jama, Polarion, ADO, and TestRail Streamline Medical Product Development](/blog/new-integrations-with-jama-and-testrail-streamline-medical-product-development.html): Explore Ketryx's new integrations with Jama, Polarion, ADO, and TestRail, keeping your teams in their preferred tools for accelerated development. (1,056 words) - [Webinars](/learn/webinars/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (1,587 words) - [“Did We Catch Everything?” How Ketryx Turns Risk Management into Proactive Product Intelligence](/blog/ai-for-risk-management/index.html): Managing complex risk documentation across hundreds of failure modes is a human cognition problem. See how AI helps teams verify completeness, without replacing engineering judgment. (2,055 words) - [Creating FDA-compliant Medical Devices at Lightning Speed with ChatGPT and Ketryx](/blog/chatgpt-and-ketryx/index.html): Learn how to combine regulations, tools and generative AI to create FDA-compliant medical devices at scale. (797 words) - [Privacy Policy](/privacy/index.html) (1,897 words) - [Agile in Theory, Waterfall in Practice: Why Regulated Teams Struggle to Ship Fast](/blog/agile-in-theory-waterfall-in-practice-why-regulated-teams-struggle-to-ship-fast.html): Learn how medical device software teams can use an agile approach to documentation and product development while staying compliant. (944 words) - [Develop fast, stay ISO 26262-compliant.](/industries/automotive/index.html): Automate ISO 26262 compliance for automotive software. Real-time traceability, AI-powered change impact analysis, and ASPICE-ready documentation. (761 words) - [FDA-Grade AI: Total Product Lifecycle Control with a PCCP](/learn/webinars/register/fda-grade-ai-total-product-lifecycle-control-with-a-pccp.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (256 words) - [How to Build Compliant Software Faster with Polarion, Jira, and Ketryx](/blog/doing-agile-development-with-jira-and-polarion/index.html): Learn how to simplify IEC 62304 compliance by integrating Jira and Polarion. Discover automated traceability solutions for medical device software teams. (833 words) - [The latest (June 2023) changes to the FDA’s new premarket submission guidance](/blog/the-latest-june-2023-changes-to-the-fdas-new-premarket-submission-guidance.html): This guidance on "Content of Premarket Submissions for Device Software Functions" outlines key changes software developers, regulatory affairs, and quality professionals need to know about the differences between the original 2005 guidance and the 2023 version., Explore the "Shared" view on Airtable. (1,721 words) - [From 7 weeks to 7 days: How a Top 5 IVD Company Transformed its Software Release Cycle](/case-studies/enterprise-ivd-company/index.html) (551 words) - [Ketryx for Nuclear Energy](/industries/nuclear-energy/index.html): Automate IEC 61513 compliance for nuclear software. Real-time traceability, AI-powered change impact analysis, and safety-case-ready documentation. (863 words) - [Why the FDA’s Most Common Warning Letter Might Surprise You](/blog/why-the-fdas-most-common-warning-letter-might-surprise-you.html): Learn where most companies are falling short during FDA audits. (1,024 words) - [Constructive Constraints: Enforcement Is the Key to Faster Medical Software Development](/blog/constructive-constraints-enforcement-faster-medical-software-development.html): Manual work required for quality and compliance often slows down MedTech developers. Here’s how you can use automated enforcement to remove common barriers. (1,865 words) - [Understanding FDA Guidance on AI in Medical Devices and Predetermined Change Control Plans (PCCPs)](/blog/understanding-fda-guidance-on-ai-in-medical-devices-and-predetermined-change-control-plans-pccps.html): Learn how the FDA's AI guidance and Predetermined Change Control Plan (PCCP) framework help medical device manufacturers manage AI/ML updates, ensure compliance, and accelerate innovation in healthcare. (2,150 words) - [Meet EU CRA requirements, keep your workflows.](/eu-cra/index.html): Learn how Ketryx maps to the key obligations of the EU Cyber Resilience Act (CRA) (Regulation (EU) 2024/2847). (993 words) - [AI/ML Leaders in Medical Device Software Development](/function/ai-ml/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (729 words) - [Ketryx for Physical AI](/industries/physical-ai/index.html): Learn how Ketryx accelerates functional safety for physical AI. (844 words) - [blog/computer-software-assurance/index.html](/blog/computer-software-assurance/index.html) (1 words) - [Compliance Software for Jira](/use-case/jira-connector/index.html): Learn how to transform Jira into IEC 62304 compliance. (531 words) - [Can MedTech Use Validated DevOps to Move as Fast as Netflix?](/blog/medtech-validated-devops-fast/index.html): Learn how MedTech companies can leverage validated DevOps practices to enhance efficiency, drive innovation, and bring medical advancements to market faster. (1,623 words) - [Accelerate Product Innovation With AI](/preview-ketryx/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (703 words) - [Ketryx 2.5](/blog/ketryx-2-5/index.html): Ketryx 2.5 marks a significant step forward with the introduction of features that streamline complexity and automate tasks that have historically demanded large amounts of manual work. Your software development life cycle (SDLC) now includes powerful integrations with templates, RTM projects, and Git-based items, all of which enable automated documentation, risk management, and traceability . Manage your vulnerabilities and accelerate your software development faster than ever with our expanded 2.5 features. (663 words) - [$14M to Build the Future of Medical Software](/blog/14m-to-build-the-future-of-medical-software/index.html): We’re now squarely in Stage 2 of our strategy, having proven we could build a repeatable product that serves enterprise companies. With today’s addition of $14 million in funding, we’ll be able to scale our operations across the company so we can continue extending our platform to enterprise medical device and SaMD manufacturers across the globe who would benefit from Ketryx. (1,236 words) - [Build safe, compliant medical device software](/function/quality/index.html): Learn how to enforce your QMS procedures with medical device quality assurance and regulatory compliance software. (626 words) - [Software as a Medical Device (SaMD) and Connected Devices](/use-case/samd/index.html): Build and maintain FDA-regulated software as a medical device in minutes. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11. (575 words) - [MedTech Trends for 2024: Takeaways from JP Morgan's Health Conference](/blog/medtech-trends-for-2024-takeaways-from-jp-morgans-health-conference.html): Among the number of groundbreaking announcements and sessions, a prominent theme at the conference was the huge momentum of digitization efforts across healthcare. (1,018 words) - [FDA Cybersecurity Guidance for Medical Devices](/blog/fda-cybersecurity-guidance-for-medical-devices/index.html): Discover how the FDA’s cybersecurity guidance helps medical device manufacturers secure their products against cybersecurity threats, ensuring compliance, patient safety, and ongoing device protection throughout the product lifecycle. (1,278 words) - [Key Takeaways from the first Safety-critical Software Meetup in Boston](/blog/key-takeaways-from-the-first-safety-critical-software-meetup-in-boston.html): The Boston Safety-critical software and AI/ML Meetup’s first discussion on regulated cloud development and the FDA had three key takeaways: the importance of validation, being prepared for the changing cloud environment, and building a safety-focused software community for better patient outcomes. (942 words) - [AI-Assisted Change Impact Assessment: How 9 Engineers Doubled Their Completeness in Half the Time](/blog/ai-assisted-change-impact-assessment-how-9-engineers-doubled-their-completeness-in-half-the-time.html): 9 engineers doubled their change impact assessment completeness in half the time using AI. See what we learned from 18 real compliance workflows. (1,574 words) - [FDA Predetermined Change Control Plan (PCCP): Compliance Guide](/blog/pccp-compliance/index.html): The Predetermined Change Control Plan (PCCP) is an innovative approach to address ML-related risk in premarket submissions for medical devices. This plan empowers manufacturers to refine and tune AI/ML algorithms through frequent deployments within the constraints of safety and effectiveness without the need to make an additional premarket submission. (1,936 words) - [**Manage and trace requirements across systems with ease**](/capabilities/requirements-management/index.html) (444 words) - [Announcing Ketryx’s UL Certification to IEC 62304, ISO 13485, and ISO 14971](/blog/announcing-ketryxs-ul-certification/index.html): Ketryx announces our UL certification for IEC 62304, ISO 14971, and ISO 13485, which helps medical device companies build validated software in an FDA-compliant way. (856 words) - [Why Change Impact Assessment Is the Hidden Bottleneck in Medical Device Development](/blog/change-impact-assessment-bottleneck/index.html): Traditional Change Impact Assessment slows medical device development and creates compliance risk. Learn how AI-powered CIA reduces cycle times by 70%. (1,206 words) - [Simplifying 510K Submissions with FDA’s eSTAR Program and Ketryx](/blog/simplifying-510k-submissions-with-fdas-estar-program-and-ketryx.html): The eSTAR program, which stands for Electronic Submission, Tracking, and Reporting, initially focuses on the 510(k) pathway for medical device clearance, including software-based devices. Traditionally, the review process involved extensive paperwork and possible rejection for issues in documentation, formatting, and other compliance related challenges. The eSTAR program provides an editable pdf document that allows users to enter information and ensure compliance with different submission guidances. (947 words) - [Ketryx 2.8](/blog/ketryx-2-8/index.html): Ketryx 2.8 is focused on enabling component reuse, system of systems, and microservice architecture. These new features enable medical device software teams to develop safer software faster. (1,117 words) - [A brief overview of cloud security for standard and safety-critical software](/blog/a-brief-overview-of-cloud-security/index.html): Learn three basic steps to fortify your cloud environment (925 words) - [Ketryx Launches First Validated AI Agents to Accelerate Safety-Critical Product Development](/press-release/ketryx-launches-first-validated-ai-agents-to-accelerate-safety-critical-product-development.html): Regulated Teams Can Remain Compliant and Accelerate Product Innovation by Automating Arduous Manual Tasks (952 words) - [Meet the Ketryx Team](/about/careers/index.html): Build the future of Safety-Critical Software with us. We are looking for the various roles to extend our team. (637 words) - [AI for Life Sciences](/use-case/gxp/index.html): Reduce the complexity, time, and cost of building validated applications. Automatically generate requirements, SRS, SDS, testing plans and reports. (443 words) - [How to Stop Managing Documents and Start Managing the Work](/blog/how-to-stop-managing-documents-and-start-managing-the-work.html): Learn how to spend less time formatting documents for regulatory compliance and instead, generate artifacts automatically to compile up-to-date evidence. (797 words) - [Regulation Isn’t Slowing MedTech. Legacy Thinking Is.](/blog/regulation-isnt-slowing-medtech-legacy-thinking-is/index.html): The biggest factor holding MedTech back today isn’t the FDA. It’s the legacy tools, processes, and infrastructure the industry still stubbornly clings to. (936 words) - [AWS](/integrations/aws/index.html) (448 words) - [Terms of Service](/terms/index.html) (5,837 words) - [SOUP Software Definition and a Guide to Software Regulations of Unknown Provenance](/blog/what-is-soup/index.html): SOUP, or Software of Unknown Provenance, is any piece of software used in a medical device that wasn’t developed for use in a medical device (i.e. under 62304) or for which such documentation doesn’t exist. (947 words) - [Work Smarter: Ketryx’s Native Google Drive Integration](/blog/work-smarter-ketryxs-native-google-drive-integration.html): Collaborate in Google Drive while Ketryx handles governance. Native integration eliminates manual uploads, accelerates approvals, and ensures compliance for regulated teams. (531 words) - [Validated — San Diego Life Sciences Networking](/ai-san-diego-meetup/index.html): Join us in San Diego during the MedTech Conference as Ketryx brings medtech leaders together for cocktails, appetizers, and real-world conversations about how teams are moving beyond outdated workflows and introducing AI into their products and processes. Hear from experts, connect with peers, and be part of a community working to bring safe, effective AI to life sciences., Connect with life sciences innovators and learn how to validate AI faster so you can bring life-changing technology to patients sooner. (321 words) - [Compliance without disrupting your workflow](/capabilities/integrations/index.html): Connect your preferred development tools, cloud infrastructure, and languages into a single traceable Software Development Life Cycle (SDLC). (512 words) - [AI-Guided Systems Engineering for Safe, Compliant, Connected Development.](/function/systems-engineering/index.html): Unify requirements, risk, testing, and change management across tools with automated traceability and AI-guided compliance for systems engineers. (818 words) - [FDA-Grade AI Compliance in Medical Device Software](/use-case/ai-ml-med-device/index.html): Enable your developers to release software frequently and use open-source AI/ML packages with regulatory compliance. (834 words) - [AI Driven Risk Management](/capabilities/risk-management/index.html) (633 words) - [Change Impact Assessment](/capabilities/change-impact-assessment/index.html): Apply AI to identify, analyze, and act on change impacts across the DHF with less manual work and greater confidence. (707 words) - [AI-Enabled Compliance for GxP Software](/use-case/ai-ml-gxp-life-science/index.html): Enable your developers to release software frequently and use open-source AI/ML packages with regulatory compliance. (605 words) - [Use of AI in imaging paves the way for other medical devices](/blog/use-of-ai-in-imaging-paves-the-way-for-other-medical-devices.html): New FDA guidance enables faster release cycles for AI medical devices, allowing continuous improvement and broader adoption while maintaining regulatory oversight, according to Ketryx CEO Erez Kaminski. (295 words) - [Build secure software. Show your work.](/capabilities/sbom-new/index.html): Learn how to manage cybersecurity risk with software bill of materials (SBOM) management for medical devices. (820 words) - [Generative AI for Regulated Teams](/use-case/gen-ai-in-your-tplc/index.html): Learn how to turn your medical device software development into FDA compliant traceability. (310 words) - [Ketryx Pricing for Connected](/pricing/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (261 words) - [The Spotify layoff letter, a new AI model from Alibaba, and a Boston VC firm abruptly shuts down](/blog/the-spotify-layoff-letter-a-new-ai-model-from-alibaba-and-a-boston-vc-firm-abruptly-shuts-down.html): Discover how Ketryx has raised a total of $18 million (319 words) - [IEC 62304-compliant traceability to automated tests for safer medical device software](/use-case/traceability-to-automated-tests/index.html) (421 words) - [Understanding Release Readiness with Ketryx Assistant](/videos/understanding-release-readiness-with-ketryx-assistant.html) (137 words) - [AI Experts Network: Innovation Labs Series](/blog/ai-experts-network-innovation-labs-series/index.html): Enhance your knowledge and insights into AI through AI Experts Focus Sessions (328 words) - [Minimizing Risk Through Model-Based Systems Engineering: A Regulatory Perspective](/blog/minimizing-risk-through-model-based-engineering/index.html): After two decades at the FDA, one lesson is clear: safer systems are proven before they’re built. Here's why model-based systems engineering matters for medical devices. (875 words) - [Open Positions](/about/open-positions/index.html): Build the future of Safety-Critical Software with us. We are looking for the various roles to extend our team. (176 words) - [AI Privacy and Confidentiality Notice](/ai-privacy-and-confidentiality/index.html) (626 words) - [How Beacon Biosignals Reduced Their Release Cycle to Two Weeks for AI/ML Products with PCCPs](/case-studies/beacon-biosignals/index.html) (668 words) - [ADO for IEC 62304 and AI: Developing FDA-Compliant Software in Azure DevOps](/learn/webinars/register/ado-for-iec-62304-and-ai-developing-fda-compliant-software-in-azure-devops.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (285 words) - [**Ketryx for Start-ups**](/stage/startup/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (355 words) - [Multiple Function Device Validation](/use-case/multifunction-device/index.html): Enable your developers to release device and non-device functions separately for your multifunction device. (537 words) - [Git for IEC 62304: Traceability for Software Design, Unit Testing & Requirements](/learn/webinars/register/git-for-iec-62304-jan-25/index.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (288 words) - [Ketryx Raises $39M Series B Round to Power the Future of Regulated Artificial Intelligence for Life Sciences](/press-release/series-b/index.html): Transformation Capital leads round to scale AI-native compliance infrastructure trusted by top Life Science and Fortune 500 companies (724 words) - [Artificial Intelligence Regulatory Compliance](/use-case/ai-ml-ivd-diagnostics/index.html): Enable your developers to release software frequently and use open-source AI/ML packages with regulatory compliance. (698 words) - [About Ketryx](/about/certifications/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (350 words) - [Why Validated DevOps is the Path Forward for Regulated Software](/blog/why-validated-devops-is-the-path-forward-for-regulated-software.html): Discover how Validated DevOps is revolutionizing innovation, ensuring regulatory adherence, and supporting AI/ML integration to deliver safer, faster, and more reliable software in healthcare and beyond. (571 words) - [Three strategies for unlocking the power of continuous integration/continuous deployment (CI/CD) for AI-powered medical devices](/blog/three-strategies-for-unlocking-the-power-of-continuous-integration-continuous-deployment-ci-cd-for-ai-powered-medical-devices.html): Discover three practical strategies to implement CI/CD for AI-powered medical devices. Learn how to design adaptable architectures, automate documentation, and maintain end-to-end traceability while ensuring compliance with evolving FDA standards. (483 words) - [Discover Why the Top MedTechs in the Industry Rely on Ketryx AI Compliance](/about/why-ketryx/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (455 words) - [Scaling AI Responsibly: Transforming MedTech and Life Sciences with Validated AI](/events/scaling-ai-responsibly-fireside-chat/index.html) (355 words) - [Ketryx Wants Its Validated AI Agents To Accelerate Compliance Workflows](/blog/ketryx-wants-its-validated-ai-agents-to-accelerate-compliance-workflows.html): Company’s Hybrid AI Architecture Combines Foundation Models With Proprietary Regulatory Grounding And Enterprise Data Integration (568 words) - [QMS Optimization Workshop Template](/white-papers/qms-optimization-workshop-template/index.html): This practical workshop template is designed to guide regulated teams in regular QMS reviews to identify process debt and apply a modern, risk-based, AI-assisted approach to quality processes. (473 words) - [Medical Device Quality Management System Software](/capabilities/enforcement/index.html): Learn how to enforce your Medical Device QMS across preferred DevTools (467 words) - [Transitioning to FDA’s New Premarket Submission Guidance: Impact on Quality Systems and Development Practices](/learn/webinars/register/transitioning-to-fdas-new-premarket-submission-guidance.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (361 words) - [StartUPDATES: New developments from healthcare startups](/blog/startupdates-new-developments-from-healthcare-startups.html): Ketryx is a startup that sells a platform — designed around FDA regulations and quality standards (166 words) - [Cursor](/integrations/cursor/index.html) (276 words) - [Ketryx raises $18M to accelerate software development cycles in the medical industry](/blog/ketryx-raises-18m-to-accelerate-software-development-cycles-in-the-medical-industry.html): Ketryx raises $18M to transform medical software development with its Connected Lifecycle Management platform, automating quality assurance and ensuring compliance with FDA standards. (330 words) - [FDA Predetermined Change Control Plan (PCCP) Template](/white-papers/pccp-template/index.html): This template is designed to assist organizations in developing a comprehensive plan to manage and assess modifications to Machine Learning Device Software Functions (ML-DSFs) in medical devices. (799 words) - [Product Spotlight Webinar: AI-Native Development & Compliance with Ketryx MCP](/learn/webinars/register/mcp-2026/index.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (301 words) - [Embedding Systems Thinking in Fast-Moving, AI-Enabled Software Teams](/learn/webinars/register/embedding-systems-thinking-in-fast-moving-ai-enabled-software-teams.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (282 words) - [Medical Device Component Reuse Software](/use-case/component-reuse/index.html): Enable your developers to release software frequently and use open-source AI/ML packages with regulatory compliance. (553 words) - [Innovation Beat: Mass. unveils plan to improve EV charging. Is it moving fast enough?](/blog/innovation-beat/index.html): 🧬 Life sciences software company Ketryx in Boston raised $14 million in a deal led by Lightspeed Venture Partners and also including MIT's E14 Fund and Ubiquity Ventures. (242 words) - [Achieve faster product releases with Ketryx's validated AI agents](/blog/achieve-faster-product-releases-with-ketryxs-validated-ai-agents.html): Ketryx announced the launch of the first validated AI agents for regulated industries. This industry-first set of validated agents will transform how highly regulated companies design, develop, and deploy new products to market. (420 words) - [Spreadsheet Errors: The Hidden Risk In MedTech](/blog/spreadsheet-errors-the-hidden-risk-in-medtech/index.html): Learn how Connected Lifecycle Management (CLM) can replace outdated manual processes like using spreadhsheets with automation, improving traceability, efficiency, and patient safety. (391 words) - [SBOM and Beyond: FDA-Compliant Cybersecurity Vulnerability Management](/learn/webinars/register/sbom-and-beyond-fda-compliant-cybersecurity-vulnerability-management-2.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (293 words) - [How to Make Jira Work for IEC 62304 Development](/learn/webinars/on-demand/how-to-make-jira-work-for-iec-62304-development/index.html) (156 words) - [learn/webinars/register/breaking-the-change-impact-assessment-bottleneck/index.html](/learn/webinars/register/breaking-the-change-impact-assessment-bottleneck/index.html) (1 words) - [Ketryx Rakes In $14M to Speed Up Medical Device Development & Quality Assurance](/blog/ketryx-rakes-in-14m-to-speed-up-medical-device-development-quality-assurance.html): Ketryx raised $14 million in Series A funds. The startups sells a platform — designed around FDA regulations and quality standards — that automates much of the work required from medical device companies’ development and quality teams. (270 words) - [From Recalls to Reliability: Tools to Ensure Software Safety in MedTech](/blog/from-recalls-to-reliability-tools-to-ensure-software-safety-in-medtech.html): Validation is paramount in ensuring trust in safety-critical devices. It confirms a device’s design follows the approved design plan for medical devices in the US. (517 words) - [Leverage AI to transform your work into a traceable, self-documenting lifecycle](/capabilities/traceability/index.html): Learn how to turn your medical device software development into FDA compliant traceability. (359 words) - [Ketryx Tackles Software Safety in Medical Devices Amid Growing Recalls](/blog/ketryx-tackles-software-safety-in-medical-devices-amid-growing-recalls.html): Lean about how Ketryx has developed a lifecycle management solution that integrates with the existing tools used by companies, allowing them to accelerate their product delivery and reduce the complexity of their lifecycle. (441 words) - [How to Survive FDA’s Predetermined Change Control Plan](/blog/how-to-survive-fdas-predetermined-change-control-plan.html): This article offers a primer on the PCCP and a strategy for companies to design their products with PCCP in mind, enabling them to leapfrog competitors still bound by traditional regulatory processes. (465 words) - [From AI Curious to AI Native: Top Use Cases For AI Across Regulated SDLCs](/learn/webinars/register/ai-curious-to-ai-native-may-2026/index.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (335 words) - [How Can Medtechs Prepare for the FDA’s Shift Left Strategy on Cybersecurity?](/blog/how-can-medtechs-prepare-for-the-fdas-shift-left-strategy-on-cybersecurity.html): Regulators have become increasingly concerned about the potential for medical devices to become a vector for spreading malware attacks across hospital networks, resulting in untold patient harm and billions of dollars globally. (341 words) - [Building an Audit-Ready Secure SDLC: Traceability Across Cybersecurity Risks & Vulnerabilities](/learn/webinars/register/building-an-audit-ready-secure-sdlc/index.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (259 words) - [Why building AI/ML-enabled Medical Devices requires CI/CD: A transition path](/learn/webinars/on-demand/why-building-ai-ml-enabled-medical-devices-requires-ci-cd-a-transition-path.html) (108 words) - [Former Medtronic CEO joins $39M Ketryx funding round](/blog/former-medtronic-ceo-joins-39m-ketryx-funding-round.html): Ketryx today announced a $39 million Series B funding round that included former Medtronic CEO Bill Hawkins as a new investor. 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(293 words) - [IDC Spotlight: Connected Life-Cycle Management Streamlines Software Development for Medical Devices](/white-papers/idc-clm-spotlight-paper/index.html): This Spotlight Paper from leading technology analyst IDC explores how Connected Lifecycle Management (CLM) is transforming software development for regulated industries. (475 words) - [Release 10x Faster with Ketryx](/schedule-demo/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11, Route your prospects through Chili Piper (271 words) - [StartUp Health Insights: GI Robotics Company Closes $42M](/blog/startup-health-insights-gi-robotics-company-closes-42m-week-of-dec-5-2023.html): AI-based startups also did well this week, with several companies using AI in imaging and drug discovery closing rounds. (207 words) - [Ketryx raises $14M in Series A funding led by Lightspeed Venture Partners](/blog/ketryx-raises-14m-in-series-a-funding-led-by-lightspeed-venture-partners.html): Ketryx, provider of a connected application lifecycle management software for the life sciences industry, has announced that it has raised $14 Million in Series A funding. (298 words) - [AI Agents Launched to Streamline Compliance in Safety-Critical Sectors](/blog/ai-agents-launched-to-streamline-compliance-in-safety-critical-sectors.html): Ketryx’s suite of AI agents is designed to help highly regulated industries move products through typically slow development processes (393 words) - [Preparing for the PATCH Act and RTA](/blog/preparing-for-the-patch-act-and-rta/index.html): Erez Kaminski, former head of AI with Amgen and founder of Ketryx, and Paul Jones, former FDA official and Executive Vice President of Ketryx, provide an overview of challenges companies face as they work to comply with the new cybersecurity regulations and standards. (277 words) - [Q&A: The facts about the PATCH Act](/blog/q-a-the-facts-about-the-patch-act/index.html): As the compliance deadline edges closer for the Protecting and Transforming Cyber Health Care Act, what do cyber device providers in the US need to do to meet the requirements and ensure a smooth transition? (310 words) - [Medtech AI developer Ketryx raises $14M in Series A round led by Lightspeed](/blog/medtech-ai-developer-ketryx-raises-14m-in-series-a-round-led-by-lightspeed.html): Ketryx raises $14M in Series A funding led by Lightspeed Venture Partners to accelerate innovation in AI-powered medical devices, ensuring patient safety and regulatory compliance through its Connected Lifecycle Management platform. (280 words) - [Validating AI & LLMs in GxP Use Cases for Pharma](/learn/webinars/on-demand/validating-ai-llms-in-gxp-use-cases-for-pharma/index.html) (212 words) - [ChatGPT](/integrations/chatgpt/index.html) (282 words) - [What Makes a Company Successful at Using AI?](/blog/what-makes-a-company-successful-at-using-ai/index.html): Vistra, a major U.S. power producer, had a problem. 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(342 words) - [Document Generation with Ketryx](/videos/document-generation-video/index.html) (158 words) - [39 Millionen Dollar Investment für österreichisch-amerikanisches KI-Start-up](/blog/39-millionen-dollar-investment-fur-osterreichisch-amerikanisches-ki-start-up.html): Das Start-up Ketryx bietet KI-gestützte Software für Medizinunternehmen. Am Standort Wien sollen neue Jobs entstehen (215 words) - [Empowering the SDLC Process with Tools to Bridge R&D and Quality](/learn/webinars/on-demand/empowering-the-sdlc-process-with-tools-to-bridge-r-d-and-quality.html) (208 words) - [Modernizing FDA-Grade Software Development with Validated DevOps](/white-papers/validated-devops-white-paper/index.html): Discover how Validated DevOps can help you develop software faster while staying compliant. (368 words) - [Ketryx Raises $39M Series B from Transformation & Lightspeed to Scale AI in MedTech](/blog/ketryx-raises-39m-series-b-from-transformation-lightspeed-to-scale-ai-in-medtech.html): Closed in just 14 days, Ketryx has raised a $39M Series B, bringing its total funding to $57M, in a round led by Transformation Capital (Vinay Shah) with participation from Lightspeed Venture Partners (Guru Chahal), MIT’s E14 Fund, Ubiquity Ventures, 53 Stations, and notable angels. Cementing Ketryx as the leader in AI compliance infrastructure layer for MedTech and beyond. (284 words) - [Four Bold Predictions for Medtech in 2025: AI Everywhere, Faster Releases, and Rising Risks](/blog/four-bold-predictions-for-medtech-in-2025-ai-everywhere-faster-releases-and-rising-risks.html): Four promising trends that medtech companies should be aware of heading into 2025 to stay ahead of competition. (492 words) - [The Cost of Quality](/white-papers/the-cost-of-quality/index.html): What is quality and why can it make creating products more expensive? What is the cost of creating high quality products? (351 words) - [AI firm Ketryx raises $39M, adds former Medtronic CEO as investor](/blog/ai-firm-ketryx-raises-39m-adds-former-medtronic-ceo-as-investor.html): The company, which helps medtech companies with AI compliance, has raised more than $55 million to date. (172 words) - [Ketryx raises $39M to help medical device makers ship safer products faster](/blog/ketryx-raises-39m-to-help-medical-device-makers-ship-safer-products-faster.html): Ketryx Corp., a company transforming product lifecycle development and compliance for medical device makers with artificial intelligence, today announced it has raised $39 million in a Series B funding round led by Transformation Capital. (247 words) - [Building an Audit-Ready Secure SDLC](/learn/webinars/on-demand/building-an-audit-ready-secure-sdlc/index.html) (212 words) - [Postmarket Surveillance of AI Systems: Proactive methods for identifying risk and improving product quality](/learn/webinars/on-demand/postmarket-surveillance-of-ai-systems-proactive-methods-for-identifying-risk-and-improving-product-quality.html) (258 words) - [62304-Compliant Traceability for Automated Testing](/learn/webinars/register/62304-compliant-traceability-for-automated-testing/index.html): As development organizations implement more Agile and DevOps processes and accelerate the velocity of software releases, the time available for rigorous testing is often sacrificed. Quality software is a must for digital transformation success, and organizations that find a way to balance the risk and rewards of that velocity understand that going fast doesn’t mean breaking things. Today’s increasing focus on costs and budgets is an opportunity to innovate quality. (312 words) - [Modernizing FDA-Grade Software Development with Validated DevOps](/assets/validated-devops-white-paper/index.html): Delivering compliant software quickly without compromising on quality is a significant challenge. Modern MedTech software development must balance innovation with stringent regulatory compliance. Regulatory requirements add layers of complexity, often leading to delayed releases and developer frustration. This white paper delves into the core challenges and provides actionable insights on how to integrate Validated DevOps to streamline your development process. (160 words) - [Life Sciences AI on Tap: Connect with Boston’s Life Sciences Community](/events/life-sciences-ai-on-tap-aug/index.html) (222 words) - [AI startup that streamlines medical device compliance raises $39M](/blog/ai-startup-that-streamlines-medical-device-compliance-raises-39m.html): A Boston-based startup trying to make medical device compliance easy, seamless and boring announced a new round of venture capital. (223 words) - [JavaScript Static Analysis Tools for Medical Devices](/white-papers/javascript-static-analysis-tools-for-medical-devices.html): The focus of this paper is on software applications written in JavaScript that meet the Food and Drug Administration’s (FDA) regulatory definition of a medical device. (348 words) - [Mary Brook Delano Named Chief Business Officer at Ketryx](/blog/mary-brook-delano-named-chief-business-officer-at-ketryx.html): Ketryx has appointed Mary Brook Delano as chief business officer, a newly created role that is responsible for leading the company’s go-to-market strategy, revenue growth, customer experience, and cross-functional commercial execution. She will report directly to CEO Erez Kaminski. (227 words) - [Navigating the FDA’s Total Product Lifecycle Framework for Generative AI Devices](/learn/webinars/on-demand/navigating-the-fdas-total-product-lifecycle-framework-for-generative-ai-devices.html) (194 words) - [Digital health's top 2023 trends, wrapped](/blog/digital-healths-top-2023-trends-wrapped/index.html): Explore Rock Health Advisory's final 2023 insights on digital health trends like AI in healthcare, GLP-1s, and retail health, and discover opportunities for impactful innovation in 2024 (220 words) - [Medtech Connect Episode 6: The Latest And Greatest In Digital Health Regulations](/blog/medtech-connect-episode-6-the-latest-and-greatest-in-digital-health-regulations.html): We will talk about some of the challenges and opportunities that often arise from regulations and Erez will share a personal story about why the safety of medical devices matters so much to him. (196 words) - [A Guide To Implementing CI/CD in Your AI/ML SaMD Projects](/white-papers/ci-cd-ai-ml-white-paper/index.html): Learn why CI/CD is crucial for AI/ML SaMD development and how you can transition your organization to CI/CD. (435 words) - [Transforming Lifecycle Management](/blog/transforming-lifecycle-management/index.html): Learn how Ketryx is a connected lifecycle management system designed to bridge the gap between modern software development practices and the rigorous compliance requirements of life science companies. (259 words) - [Regulatory Pathways](/white-papers/regulatory-pathways/index.html): Learn about the different approval pathways possible, and how to find the one that works best for you. (282 words) - [The Future of Healthcare Is Connected & Data-Driven](/blog/the-future-of-healthcare-is-connected-data-driven/index.html): Erez Kaminski, CEO & Founder of Ketryx, spoke about the reality of developing cloud-based software in a changing regulatory environment. 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(182 words) - [Erez Kaminski, Co-Founder & CEO at Ketryx on serving 100M+ customers and scaling regulated products](/blog/the-lantern-erez-kaminski-co-founder-ceo-at-ketryx-on-serving-100m-customers-and-scaling-regulated-products.html): Erez Kaminski, Co-Founder & CEO of Ketryx, joins The Lantern to share how a $39M Series B, 4 of the top 5 medical device companies, and 100M patients impacted are reshaping regulated product development. (269 words) - [Inside the FDA Regulatory Process](/assets/inside-the-fda-regulatory-process/index.html): Understanding the background and motivating factors for FDA’s Center for Devices and Radiological Health (CDRH) and the Office of Regulatory Affairs personnel will help you get a better understanding of how to prepare submissions. This eBook, written by former FDA Paul Jones, addresses the basic structure, training, and background of FDA personnel, the most common mistakes he sees companies make while building and maintaining software, and what to expect during an audit, as well as good standard practices for avoiding fines and warning letters. (147 words) - [Ketryx Raises $14M in Series A Funding](/blog/ketryx-raises-14m-in-series-a-funding-2/index.html): Ketryx secures $14M in Series A funding to advance its Connected Lifecycle Management platform, streamlining regulated software development for the life sciences industry while enhancing quality and compliance. (189 words) - [A Playbook for Transforming Jira to Support IEC 62304 Compliance](/white-papers/a-playbook-for-transforming-jira-to-support-iec-62304-compliance.html): To bridge the gap between Jira’s capabilities and IEC 62304 requirements, Ketryx offers integration that extends Jira’s functionality to support compliance. Learn how Ketryx transforms Jira into a powerful tool for IEC 62304-compliant software development. (454 words) - [The Transformative Impact of Patient Apps in Healthcare](/blog/the-transformative-impact-of-patient-apps-in-healthcare.html): How is healthcare adopting Remote Patient Monitoring (RPM) and Remote Therapeutic Patient Monitoring? (295 words) - [American Medical Device Summit](/events/american-medical-device-summit-2026/index.html) (81 words) - [Ketryx: Application Lifecycle Management Company Raises $14 Million](/blog/ketryx-application-lifecycle-management-company-raises-14-million.html): Ketryx – a provider of the first and only connected application lifecycle management software for the life sciences industry – recently announced that it has raised $14 Million in Series A funding. 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Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11, Route your prospects through Chili Piper (302 words) - [INCOSE Systems Engineering in Healthcare Conference](/events/incose-systems-engineering-in-healthcare-conference.html) (83 words) - [FDA Cyber Guidance and the Software Supply Chain: A Playbook for Shifting Left](/white-papers/fda-cyber-guidance-and-the-software-supply-chain-a-playbook-for-shifting-left.html): Discover how to navigate the complex landscape of cybersecurity for medical devices with this comprehensive guide. (382 words) - [Digital Health & AI Innovation Summit](/events/digital-health-ai-innovation-summit/index.html) (83 words) - [JavaScript Static Analysis Tools for Medical Devices](/assets/javascript-static-analysis-tools-for-medical-devices.html): The focus of this paper is on software applications (Apps) written in Javascript that meet the Food and Drug Administration’s (FDA) regulatory definition of a medical device. Because medical devices are used to treat, diagnose, deliver therapy, etc. their use may result in patient harm, ranging from minor injuries to death. Therefore, freedom from unacceptable risk (safety) is an imperative, and security is a subset of safety. (139 words) - [INCOSE International Symposium](/events/incose-international-symposium/index.html) (80 words) - [Imprint](/imprint/index.html) (84 words) - [Careers at Ketryx](/careers-at-ketryx-interest/index.html): Build and maintain FDA-regulated software infrastructure in minutes, not months. Software tooling built for IEC 62304, GMP, ISO 13485, and CFR 21 Part 820/11 (83 words) - [learn/blog/index.html](/learn/blog/index.html) (1 words) - [blog/qms-dhf-dmr-and-everything-in-between/index.html](/blog/qms-dhf-dmr-and-everything-in-between/index.html) (1 words) ## Resources - [Full Page Index](/index.html): Browse all cached pages with rich metadata - [About This Cache](/content/about.html): Methodology, technical details, and usage guidelines - [XML Sitemap](/content/sitemap.xml): Machine-readable sitemap for crawler discovery - [Robots.txt](/content/robots.txt): Crawler directives