blog/
139 pages · Updated May 25, 2026
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- blog/the-compliance-confidence-trap-what-100-requirements-reviews-still-miss.html
- blog/understanding-the-fdas-2026-clinical-decision-support-software-guidance-what-medical-device-companies-need-to-know.html
- blog/story-of-ketryx/index.html
- blog/we-put-our-own-qms-under-the-microscope-heres-what-we-found.html
- blog/understanding-software-as-a-medical-device-samd/index.html
- blog/ketryx-ai-agents/index.html
- blog/ketryx-2-9/index.html
- blog/ketryx-intelligence/index.html
- Oh no, you've reached a page that's been uprooted.
- blog/a-comprehensive-guide-to-iec-62304-navigating-the-standard-for-medical-device-software.html
- Recalls Are Rising. Panic Doesn’t Have To.
- Why Obsessing Over Documentation Might Be Making Your Product Less Safe
- Watch how Ketryx applies AI to automate compliance in regulated software
- Navigating ISO 26262 and IEC 61508-3 Functional Safety Standards for Safety-Critical Software
- How to Validate Ketryx
- Why The Epidemic In Quality Failures And What MedTechs Can Learn
- Three steps for traceability in medical device software development quality and compliance
- The VentureFizz Podcast with Erez Kaminski
- Ketryx Raises $14 Million to Boost Software Safety in Healthcare
- MIT Media Lab Spring Meeting 2022: E14 Startups
- Ketryx raises $14m in Series A funding
- UL Certification: A Launchpad for Product Development Excellence
- How to Build Safer and More Reliable Software
- Top of the Morning
- Ketryx raises $39M to advance AI compliance in life sciences
- Ketryx raises $39 million in Series B funding to expand AI compliance tools for life sciences
- Ketryx raises $39m to advance AI compliance platform
- blog/why-so-many-medical-device-companies-lack-real-time-traceability-and-visibility.html
- blog/ketryx-2-11/index.html
- blog/fda-drops-an-sbom/index.html
- blog/fda-software-verification-vs-validation-whats-the-difference.html
- blog/ado-integration/index.html
- blog/process-and-tooling/index.html
- blog/the-fda-just-published-free-advice-for-building-with-ai.html
- blog/building-fda-compliant-sboms-for-medtech/index.html
- blog/medtech-compliance-not-regulation-is-stifling-innovation.html
- blog/iso-14971-a-comprehensive-guide-to-risk-management-in-medical-devices.html
- blog/how-ketryx-works-product-design-philosophy-and-framework.html
- blog/ketryx-2-6/index.html
- blog/how-medtechs-can-retain-developers/index.html
- blog/building-the-infrastructure-for-regulated-ai-announcing-ketryx-39m-series-b.html
- blog/patch-act-how-to-comply-in-2023-beyond/index.html
- blog/the-best-rtm-tools-for-agile-teams-looking-beyond-excel.html
- blog/best-practices-for-maintaining-a-requirement-traceability-matrix-in-agile.html
- blog/implementing-pccp-ci-cd-for-ai-ml-enabled-medical-devices-a-comprehensive-guide.html
- blog/fda-class-ii-medical-device-regulations-and-compliance.html
- blog/how-to-create-a-design-history-file-dhf-for-medical-devices.html
- blog/fda-class-i-medical-device-regulations-and-compliance.html
- IEC 62304 & Requirements Traceability Matrix (RTM) in Jira: A Guide for Medical Device Companies
- blog/how-regulated-teams-release-every-two-weeks/index.html
- blog/how-connected-lifecycle-management-is-revolutionizing-medtech-software-development.html
- blog/ketryx-2-0-release/index.html
- blog/navigating-the-fdas-new-draft-guidance-on-ai-enabled-devices.html
- blog/traceability-101/index.html
- blog/the-ultimate-guide-to-requirements-traceability-matrix-rtm.html
- blog/how-to-generate-an-sbom-software-bill-of-materials-fast.html
- blog/inside-ketryxs-customer-validation-package/index.html
- blog/from-spreadsheets-to-system-level-clarity-how-medical-device-manufacturers-are-transforming-cybersecurity-threat-modeling.html
- blog/ai-agents-quality-impact/index.html
- blog/2023-fda-warning-letters-and-software-validation/index.html
- blog/modernizing-the-medical-device-factory-to-work-with-software.html
- blog/a-complete-guide-to-the-fdas-ai-ml-guidance-for-medical-devices.html
- blog/21-cfr-part-11-compliance-guide-for-jira-atlassian/index.html
- blog/clinical-trial-computerized-systems-regulation-review.html
- Ketryx 2.7
- blog/the-turtle-problem/index.html
- New Integrations with Jama, Polarion, ADO, and TestRail Streamline Medical Product Development
- “Did We Catch Everything?” How Ketryx Turns Risk Management into Proactive Product Intelligence
- Creating FDA-compliant Medical Devices at Lightning Speed with ChatGPT and Ketryx
- Agile in Theory, Waterfall in Practice: Why Regulated Teams Struggle to Ship Fast
- How to Build Compliant Software Faster with Polarion, Jira, and Ketryx
- The latest (June 2023) changes to the FDA’s new premarket submission guidance
- Why the FDA’s Most Common Warning Letter Might Surprise You
- Constructive Constraints: Enforcement Is the Key to Faster Medical Software Development
- Understanding FDA Guidance on AI in Medical Devices and Predetermined Change Control Plans (PCCPs)
- blog/computer-software-assurance/index.html
- Can MedTech Use Validated DevOps to Move as Fast as Netflix?
- Ketryx 2.5
- $14M to Build the Future of Medical Software
- MedTech Trends for 2024: Takeaways from JP Morgan's Health Conference
- FDA Cybersecurity Guidance for Medical Devices
- Key Takeaways from the first Safety-critical Software Meetup in Boston
- AI-Assisted Change Impact Assessment: How 9 Engineers Doubled Their Completeness in Half the Time
- FDA Predetermined Change Control Plan (PCCP): Compliance Guide
- Announcing Ketryx’s UL Certification to IEC 62304, ISO 13485, and ISO 14971
- Why Change Impact Assessment Is the Hidden Bottleneck in Medical Device Development
- Simplifying 510K Submissions with FDA’s eSTAR Program and Ketryx
- Ketryx 2.8
- A brief overview of cloud security for standard and safety-critical software
- How to Stop Managing Documents and Start Managing the Work
- Regulation Isn’t Slowing MedTech. Legacy Thinking Is.
- SOUP Software Definition and a Guide to Software Regulations of Unknown Provenance
- Work Smarter: Ketryx’s Native Google Drive Integration
- Use of AI in imaging paves the way for other medical devices
- The Spotify layoff letter, a new AI model from Alibaba, and a Boston VC firm abruptly shuts down
- AI Experts Network: Innovation Labs Series
- Minimizing Risk Through Model-Based Systems Engineering: A Regulatory Perspective
- Why Validated DevOps is the Path Forward for Regulated Software
- Three strategies for unlocking the power of continuous integration/continuous deployment (CI/CD) for AI-powered medical devices
- Ketryx Wants Its Validated AI Agents To Accelerate Compliance Workflows
- StartUPDATES: New developments from healthcare startups
- Ketryx raises $18M to accelerate software development cycles in the medical industry
- Innovation Beat: Mass. unveils plan to improve EV charging. Is it moving fast enough?
- Achieve faster product releases with Ketryx's validated AI agents
- Spreadsheet Errors: The Hidden Risk In MedTech
- Ketryx Rakes In $14M to Speed Up Medical Device Development & Quality Assurance
- From Recalls to Reliability: Tools to Ensure Software Safety in MedTech
- Ketryx Tackles Software Safety in Medical Devices Amid Growing Recalls
- How to Survive FDA’s Predetermined Change Control Plan
- How Can Medtechs Prepare for the FDA’s Shift Left Strategy on Cybersecurity?
- Former Medtronic CEO joins $39M Ketryx funding round
- As FDA moves builds out ‘Elsa,’ this AI compliance CEO underscores that need for a hybrid AI approach
- Who pays the bills when AI kills?
- Ketryx expands to larger Cambridge office as demand for AI agents grows
- StartUp Health Insights: GI Robotics Company Closes $42M
- Ketryx raises $14M in Series A funding led by Lightspeed Venture Partners
- AI Agents Launched to Streamline Compliance in Safety-Critical Sectors
- Preparing for the PATCH Act and RTA
- Q&A: The facts about the PATCH Act
- Medtech AI developer Ketryx raises $14M in Series A round led by Lightspeed
- What Makes a Company Successful at Using AI?
- Solving the Systems Interconnectivity Problem
- 39 Millionen Dollar Investment für österreichisch-amerikanisches KI-Start-up
- Ketryx Raises $39M Series B from Transformation & Lightspeed to Scale AI in MedTech
- Four Bold Predictions for Medtech in 2025: AI Everywhere, Faster Releases, and Rising Risks
- AI firm Ketryx raises $39M, adds former Medtronic CEO as investor
- Ketryx raises $39M to help medical device makers ship safer products faster
- AI startup that streamlines medical device compliance raises $39M
- Mary Brook Delano Named Chief Business Officer at Ketryx
- Digital health's top 2023 trends, wrapped
- Medtech Connect Episode 6: The Latest And Greatest In Digital Health Regulations
- Transforming Lifecycle Management
- The Future of Healthcare Is Connected & Data-Driven
- How Flo Health Built FDA-Ready Infrastructure Without Slowing Innovation
- Erez Kaminski, Co-Founder & CEO at Ketryx on serving 100M+ customers and scaling regulated products
- Ketryx Raises $14M in Series A Funding
- The Transformative Impact of Patient Apps in Healthcare
- Ketryx: Application Lifecycle Management Company Raises $14 Million
- blog/qms-dhf-dmr-and-everything-in-between/index.html