Ketryx SaMD Blog - Ketryx
[Perspectives\ \ Writing Code Before Design Controls is Not Only Legal, It’s the Future of Product Development\ \ Erez Kaminski\ \ and \ \ Paul Jones\ \ • \ \ June 15, 2026\ \ June 15, 2026\ \ Why iterative, AI-assisted development is compatible with FDA rules, IEC 62304, and GPSV.\ \
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Traceability to Automated Tests
\ \ Perspectives\ You Can't Validate AI You Don't Control: Closing the Context Gap in Regulated Development\ \ Lee Chickering\ \ and \ \ • \ \ July 8, 2026\ \ July 7, 2026](/content/blog/you-cant-validate-ai-you-dont-control-closing-the-context-gap-in-regulated-development/index.html)
\ \ Perspectives\ Writing Code Before Design Controls is Not Only Legal, It’s the Future of Product Development\ \ Erez Kaminski\ \ and \ \ Paul Jones\ \ • \ \ June 16, 2026\ \ June 15, 2026](/content/blog/writing-code-before-design-controls-is-not-only-legal-its-the-future-of-product-development/index.html)
\ \ Perspectives\ Ketryx is now ISO 27001 certified.\ \ Lee Chickering\ \ and \ \ • \ \ June 18, 2026\ \ May 29, 2026](/content/blog/ketryx-is-now-iso-27001-certified/index.html)
\ \ Academy\ Navigating Non-Product Software Validation in GxP Environments\ \ Yashaswini Maregowda\ \ and \ \ • \ \ June 11, 2026\ \ May 11, 2026](/content/blog/navigating-non-product-software-validation-in-gxp-environments/index.html)
\ \ Perspectives\ The FDA Just Published Free Advice for Building With AI. Here's What Your Team Needs to Know.\ \ Erez Kaminski\ \ and \ \ • \ \ July 14, 2026\ \ April 20, 2026](/content/blog/the-fda-just-published-free-advice-for-building-with-ai/index.html)
\ \ Academy\ From Spreadsheets to System-Level Clarity: How Medical Device Manufacturers Are Transforming Cybersecurity Threat Modeling\ \ Iskender Mambetkadyrov\ \ and \ \ • \ \ April 20, 2026\ \ April 20, 2026](/content/blog/from-spreadsheets-to-system-level-clarity-how-medical-device-manufacturers-are-transforming-cybersecurity-threat-modeling/index.html)
\ \ Academy\ Understanding the FDA's 2026 Clinical Decision Support Software Guidance: What Medical Device Companies NTK\ \ Yashaswini Maregowda\ \ and \ \ • \ \ April 10, 2026\ \ April 7, 2026](/content/blog/understanding-the-fdas-2026-clinical-decision-support-software-guidance-what-medical-device-companies-need-to-know/index.html)
\ \ Academy\ How to Create a Design and Development File for Medical Devices\ \ Lee Chickering\ \ and \ \ • \ \ April 6, 2026\ \ April 3, 2026](/content/blog/how-to-create-a-design-history-file-dhf-for-medical-devices/index.html)
\ \ Perspectives\ Regulation Isn’t Slowing MedTech. Legacy Thinking Is.\ \ Paul Jones\ \ and \ \ • \ \ March 30, 2026\ \ March 26, 2026](/content/blog/regulation-isnt-slowing-medtech-legacy-thinking-is/index.html)
\ \ Perspectives\ The Compliance Confidence Trap: What 100 Requirements Reviews Still Miss\ \ Megan Mannino\ \ and \ \ • \ \ July 14, 2026\ \ March 20, 2026](/content/blog/the-compliance-confidence-trap-what-100-requirements-reviews-still-miss/index.html)
\ \ Academy\ Navigating ISO 26262 and IEC 61508-3 Functional Safety Standards for Safety-Critical Software\ \ Yashaswini Maregowda\ \ and \ \ • \ \ April 10, 2026\ \ March 18, 2026](/content/blog/navigating-iso-26262-and-iec-61508-3-functional-safety-standards/index.html)
\ \ Perspectives\ “Did We Catch Everything?” How Ketryx Turns Risk Management into Proactive Product Intelligence\ \ Megan Mannino\ \ and \ \ • \ \ July 14, 2026\ \ March 12, 2026](/content/blog/ai-for-risk-management/index.html)
\ \ Perspectives\ Minimizing Risk Through Model-Based Systems Engineering: A Regulatory Perspective\ \ Paul Jones\ \ and \ \ • \ \ March 26, 2026\ \ March 9, 2026](/content/blog/minimizing-risk-through-model-based-engineering/index.html)
\ \ Perspectives\ AI-Assisted Change Impact Assessment: How 9 Engineers Doubled Their Completeness in Half the Time\ \ Megan Mannino\ \ and \ \ • \ \ July 14, 2026\ \ March 3, 2026](/content/blog/ai-assisted-change-impact-assessment-how-9-engineers-doubled-their-completeness-in-half-the-time/index.html)
\ \ Perspectives\ Why Change Impact Assessment Is the Hidden Bottleneck in Medical Device Development\ \ Megan Mannino\ \ and \ \ • \ \ July 14, 2026\ \ February 19, 2026](/content/blog/change-impact-assessment-bottleneck/index.html)
\ \ Perspectives\ Recalls Are Rising. Panic Doesn’t Have To.\ \ Paul Jones\ \ and \ \ • \ \ March 26, 2026\ \ February 10, 2026](/content/blog/recalls-are-rising-panic-doesnt-have-to/index.html)
\ \ Product Updates\ Work Smarter: Ketryx’s Native Google Drive Integration\ \ Gabriel Pascualy\ \ and \ \ • \ \ March 26, 2026\ \ February 3, 2026](/content/blog/work-smarter-ketryxs-native-google-drive-integration/index.html)
\ \ Perspectives\ Inside Ketryx’s Customer Validation Package\ \ Lee Chickering\ \ and \ \ • \ \ March 19, 2026\ \ December 12, 2025](/content/blog/inside-ketryxs-customer-validation-package/index.html)
\ \ Perspectives\ How Quality Teams Are Using AI Agents to Scale Their Impact\ \ Lee Chickering\ \ and \ \ • \ \ March 19, 2026\ \ November 12, 2025](/content/blog/ai-agents-quality-impact/index.html)
\ \ Perspectives\ We Put Our Own QMS Under the Microscope. Here’s What We Found.\ \ Lee Chickering\ \ and \ \ • \ \ March 19, 2026\ \ November 7, 2025](/content/blog/we-put-our-own-qms-under-the-microscope-heres-what-we-found/index.html)
\ \ Perspectives\ How to Stop Managing Documents and Start Managing the Work\ \ Lee Chickering\ \ and \ \ • \ \ March 19, 2026\ \ November 4, 2025](/content/blog/how-to-stop-managing-documents-and-start-managing-the-work/index.html)
\ \ In the News\ The VentureFizz Podcast with Erez Kaminski\ \ Ketryx\ \ and \ \ VentureFizz\ \ • \ \ July 14, 2026\ \ September 15, 2025](/content/blog/the-venturefizz-podcast-with-erez-kaminski/index.html)
\ \ Perspectives\ Building the Infrastructure for Regulated AI: Announcing Ketryx's $39M Series B\ \ Erez Kaminski\ \ and \ \ • \ \ March 19, 2026\ \ September 4, 2025](/content/blog/building-the-infrastructure-for-regulated-ai-announcing-ketryx-39m-series-b/index.html)
\ \ Perspectives\ Agile in Theory, Waterfall in Practice: Why Regulated Teams Struggle to Ship Fast\ \ Lee Chickering\ \ and \ \ • \ \ March 19, 2026\ \ August 27, 2025](/content/blog/agile-in-theory-waterfall-in-practice-why-regulated-teams-struggle-to-ship-fast/index.html)
\ \ Perspectives\ Why Obsessing Over Documentation Might Be Making Your Product Less Safe\ \ Lee Chickering\ \ and \ \ • \ \ March 19, 2026\ \ August 22, 2025](/content/blog/document-centric-approach/index.html)
\ \ Perspectives\ How Regulated Teams Release Every Two Weeks\ \ Lee Chickering\ \ and \ \ • \ \ March 19, 2026\ \ August 19, 2025](/content/blog/how-regulated-teams-release-every-two-weeks/index.html)
\ \ Perspectives\ How to Validate Ketryx\ \ Lee Chickering\ \ and \ \ • \ \ June 22, 2026\ \ August 12, 2025](/content/blog/how-to-validate-ketryx/index.html)
\ \ In the News\ Use of AI in imaging paves the way for other medical devices\ \ Ketryx\ \ and \ \ Boston Business Journal\ \ • \ \ March 19, 2026\ \ July 31, 2025](/content/blog/use-of-ai-in-imaging-paves-the-way-for-other-medical-devices/index.html)
\ \ In the News\ Ketryx expands to larger Cambridge office as demand for AI agents grows\ \ Ketryx\ \ and \ \ BostInno\ \ • \ \ March 19, 2026\ \ July 9, 2025](/content/blog/ketryx-expands-to-larger-cambridge-office-as-demand-for-ai-agents-grows/index.html)
\ \ In the News\ As FDA moves builds out ‘Elsa,’ this AI compliance CEO underscores that need for a hybrid AI approach\ \ Ketryx\ \ and \ \ R&D World\ \ • \ \ March 19, 2026\ \ June 16, 2025](/content/blog/as-fda-moves-builds-out-elsa-this-ai-compliance-ceo-underscores-that-need-for-a-hybrid-ai-approach/index.html)
\ \ Academy\ How to Build Compliant Software Faster with Polarion, Jira, and Ketryx\ \ Ketryx\ \ and \ \ • \ \ March 19, 2026\ \ June 11, 2025](/content/blog/doing-agile-development-with-jira-and-polarion/index.html)
\ \ In the News\ Ketryx Wants Its Validated AI Agents To Accelerate Compliance Workflows\ \ Shubham Singh\ \ and \ \ Citeline\ \ • \ \ May 27, 2025\ \ May 15, 2025](/content/blog/ketryx-wants-its-validated-ai-agents-to-accelerate-compliance-workflows/index.html)
\ \ In the News\ Achieve faster product releases with Ketryx's validated AI agents\ \ Elizabeth Engler Modic\ \ and \ \ Today's Medical Developments\ \ • \ \ May 2, 2025\ \ May 2, 2025](/content/blog/achieve-faster-product-releases-with-ketryxs-validated-ai-agents/index.html)
\ \ In the News\ AI Agents Launched to Streamline Compliance in Safety-Critical Sectors\ \ Scarlett Evans\ \ and \ \ AI Business\ \ • \ \ May 2, 2025\ \ May 2, 2025](/content/blog/ai-agents-launched-to-streamline-compliance-in-safety-critical-sectors/index.html)
\ \ Product Updates\ Ketryx AI Agents: How People and Agents Build Regulated Products Together\ \ Erez Kaminski\ \ and \ \ • \ \ March 19, 2026\ \ May 1, 2025](/content/blog/ketryx-ai-agents/index.html)
.svg).svg)\ \ Product Updates\ Ketryx’s New Integration with Azure DevOps (ADO): End-to-End Traceability for Regulated Teams\ \ Milan Dzenovljanovic\ \ and \ \ • \ \ March 19, 2026\ \ March 20, 2025](/content/blog/ado-integration/index.html)
\ \ Academy\ A Complete Guide to the FDA’s AI/ML Guidance for Medical Devices\ \ Lee Chickering\ \ and \ \ • \ \ March 26, 2026\ \ February 20, 2025](/content/blog/a-complete-guide-to-the-fdas-ai-ml-guidance-for-medical-devices/index.html)
\ \ Academy\ Understanding Software as a Medical Device (SaMD)\ \ Lee Chickering\ \ and \ \ • \ \ March 26, 2026\ \ January 31, 2025](/content/blog/understanding-software-as-a-medical-device-samd/index.html)
\ \ In the News\ Why Validated DevOps is the Path Forward for Regulated Software\ \ Erez Kaminski\ \ and \ \ Erez Kaminski\ \ devops.com\ \ • \ \ March 19, 2026\ \ January 30, 2025](/content/blog/why-validated-devops-is-the-path-forward-for-regulated-software/index.html)
\ \ In the News\ Spreadsheet Errors: The Hidden Risk In MedTech\ \ Erez Kaminski\ \ and \ \ Forbes\ \ • \ \ July 14, 2026\ \ January 28, 2025](/content/blog/spreadsheet-errors-the-hidden-risk-in-medtech/index.html)
\ \ Academy\ FDA Software Verification vs. Validation: What's the Difference?\ \ Lee Chickering\ \ and \ \ • \ \ March 19, 2026\ \ January 27, 2025](/content/blog/fda-software-verification-vs-validation-whats-the-difference/index.html)
.svg)\ \ Product Updates\ Ketryx 2.11\ \ Erez Kaminski\ \ and \ \ • \ \ March 19, 2026\ \ January 27, 2025](/content/blog/ketryx-2-11/index.html)
\ \ Product Updates\ New Integrations with Jama, Polarion, ADO, and TestRail Streamline Medical Product Development\ \ Milan Dzenovljanovic\ \ and \ \ • \ \ July 14, 2026\ \ January 17, 2025](/content/blog/new-integrations-with-jama-and-testrail-streamline-medical-product-development/index.html)
\ \ Perspectives\ Navigating the FDA's New Draft Guidance on AI-Enabled Devices\ \ Jenn Dixon\ \ and \ \ • \ \ March 26, 2026\ \ January 14, 2025](/content/blog/navigating-the-fdas-new-draft-guidance-on-ai-enabled-devices/index.html)
\ \ In the News\ Transforming Lifecycle Management\ \ Sandra Rodriguez\ \ and \ \ Axendia\ \ • \ \ March 19, 2026\ \ January 10, 2025](/content/blog/transforming-lifecycle-management/index.html)
\ \ Product Updates\ Introducing Ketryx Intelligence: Accelerate Product Development Safely with Generative AI\ \ Erez Kaminski\ \ and \ \ • \ \ July 14, 2026\ \ December 30, 2024](/content/blog/ketryx-intelligence/index.html)
\ \ In the News\ Four Bold Predictions for Medtech in 2025: AI Everywhere, Faster Releases, and Rising Risks\ \ Erez Kaminski\ \ and \ \ MPO News\ \ • \ \ March 19, 2026\ \ December 18, 2024](/content/blog/four-bold-predictions-for-medtech-in-2025-ai-everywhere-faster-releases-and-rising-risks/index.html)
\ \ In the News\ Three strategies for unlocking the power of continuous integration/continuous deployment (CI/CD) for AI-powered medical devices\ \ Erez Kaminski\ \ and \ \ Medical Design & Outsourcing\ \ • \ \ March 19, 2026\ \ November 12, 2024](/content/blog/three-strategies-for-unlocking-the-power-of-continuous-integration-continuous-deployment-ci-cd-for-ai-powered-medical-devices/index.html)
\ \ Perspectives\ Why So Many Medical Device Companies Lack Real-Time Traceability and Visibility\ \ Jake Stowe\ \ and \ \ • \ \ March 19, 2026\ \ November 12, 2024](/content/blog/why-so-many-medical-device-companies-lack-real-time-traceability-and-visibility/index.html)
\ \ Perspectives\ How MedTechs Can Retain Developers\ \ Jan Pöschko\ \ and \ \ • \ \ March 26, 2026\ \ November 11, 2024](/content/blog/how-medtechs-can-retain-developers/index.html)
\ \ In the News\ Why The Epidemic In Quality Failures And What MedTechs Can Learn\ \ Erez Kaminski\ \ and \ \ Forbes\ \ • \ \ March 19, 2026\ \ November 8, 2024](/content/blog/why-the-epidemic-in-quality-failures-and-what-medtechs-can-learn/index.html)
\ \ Perspectives\ How Ketryx Works: Product Design Philosophy and Framework\ \ Jan Pöschko\ \ and \ \ • \ \ March 19, 2026\ \ November 8, 2024](/content/blog/how-ketryx-works-product-design-philosophy-and-framework/index.html)
\ \ Academy\ ISO 14971: A Comprehensive Guide to Risk Management in Medical Devices\ \ Lee Chickering\ \ and \ \ • \ \ March 19, 2026\ \ November 7, 2024](/content/blog/iso-14971-a-comprehensive-guide-to-risk-management-in-medical-devices/index.html)
.svg)\ \ Academy\ A Comprehensive Guide to IEC 62304: Navigating the Standard for Medical Device Software\ \ Lee Chickering\ \ and \ \ • \ \ March 26, 2026\ \ October 23, 2024](/content/blog/a-comprehensive-guide-to-iec-62304-navigating-the-standard-for-medical-device-software/index.html)
\ \ Academy\ Understanding FDA Guidance on AI in Medical Devices and Predetermined Change Control Plans (PCCPs)\ \ Lee Chickering\ \ and \ \ • \ \ March 26, 2026\ \ October 22, 2024](/content/blog/understanding-fda-guidance-on-ai-in-medical-devices-and-predetermined-change-control-plans-pccps/index.html)
.svg)\ \ Perspectives\ Should You Change Your Process Before You Update Your Tooling?\ \ Jake Stowe\ \ and \ \ • \ \ March 19, 2026\ \ October 16, 2024](/content/blog/process-and-tooling/index.html)
\ \ Academy\ FDA Cybersecurity Guidance for Medical Devices\ \ Gabriel Pascualy\ \ and \ \ • \ \ March 26, 2026\ \ October 15, 2024](/content/blog/fda-cybersecurity-guidance-for-medical-devices/index.html)
.png)\ \ Product Updates\ Ketryx 2.9\ \ Erez Kaminski\ \ and \ \ • \ \ March 19, 2026\ \ October 14, 2024](/content/blog/ketryx-2-9/index.html)
\ \ Academy\ Implementing a PCCP & CI/CD for AI/ML-Enabled Medical Devices: A Comprehensive Guide\ \ Lee Chickering\ \ and \ \ • \ \ March 26, 2026\ \ October 11, 2024](/content/blog/implementing-pccp-ci-cd-for-ai-ml-enabled-medical-devices-a-comprehensive-guide/index.html)
\ \ Academy\ FDA Class II Medical Device Regulations and Compliance\ \ Jenn Dixon\ \ and \ \ • \ \ March 26, 2026\ \ October 3, 2024](/content/blog/fda-class-ii-medical-device-regulations-and-compliance/index.html)
\ \ Academy\ FDA Class I Medical Device Regulations and Compliance\ \ Jenn Dixon\ \ and \ \ • \ \ March 26, 2026\ \ October 2, 2024](/content/blog/fda-class-i-medical-device-regulations-and-compliance/index.html)
\ \ Perspectives\ From Vision to Validation: The Story Behind Ketryx's Journey to Transforming MedTech Software\ \ Erez Kaminski\ \ and \ \ • \ \ March 19, 2026\ \ October 1, 2024](/content/blog/story-of-ketryx/index.html)
\ \ In the News\ How to Survive FDA’s Predetermined Change Control Plan\ \ Erez Kaminski\ \ and \ \ MD+DI\ \ • \ \ March 19, 2026\ \ September 10, 2024](/content/blog/how-to-survive-fdas-predetermined-change-control-plan/index.html)
\ \ Perspectives\ Modernizing the Medical Device Factory to Work With Software\ \ Erez Kaminski\ \ and \ \ • \ \ March 19, 2026\ \ September 4, 2024](/content/blog/modernizing-the-medical-device-factory-to-work-with-software/index.html)
\ \ In the News\ Ketryx Tackles Software Safety in Medical Devices Amid Growing Recalls\ \ Jenna Philpott\ \ and \ \ Medical Device Network\ \ • \ \ March 26, 2026\ \ September 2, 2024](/content/blog/ketryx-tackles-software-safety-in-medical-devices-amid-growing-recalls/index.html)
.svg)\ \ Perspectives\ Constructive Constraints: Enforcement Is the Key to Faster Medical Software Development\ \ Jan Pöschko\ \ and \ \ • \ \ March 26, 2026\ \ August 29, 2024](/content/blog/constructive-constraints-enforcement-faster-medical-software-development/index.html)
.png)\ \ Product Updates\ Ketryx 2.8\ \ Erez Kaminski\ \ and \ \ • \ \ March 19, 2026\ \ August 21, 2024](/content/blog/ketryx-2-8/index.html)
\ \ Perspectives\ Beyond the Basics: Building FDA-Compliant SBOMs for MedTech\ \ Gabriel Pascualy\ \ and \ \ • \ \ March 26, 2026\ \ August 8, 2024](/content/blog/building-fda-compliant-sboms-for-medtech/index.html)
\ \ Perspectives\ How Connected Lifecycle Management Is Revolutionizing MedTech Software Development\ \ Zack Jha\ \ and \ \ • \ \ March 26, 2026\ \ August 5, 2024](/content/blog/how-connected-lifecycle-management-is-revolutionizing-medtech-software-development/index.html)
\ \ Perspectives\ Can MedTech Use Validated DevOps to Move as Fast as Netflix?\ \ Erez Kaminski\ \ and \ \ • \ \ March 19, 2026\ \ July 31, 2024](/content/blog/medtech-validated-devops-fast/index.html)
\ \ In the News\ Medtech compliance — not regulation — is stifling innovation\ \ Erez Kaminski\ \ and \ \ STATNews\ \ • \ \ March 19, 2026\ \ July 26, 2024](/content/blog/medtech-compliance-not-regulation-is-stifling-innovation/index.html)
\ \ In the News\ From Recalls to Reliability: Tools to Ensure Software Safety in MedTech\ \ Erez Kaminski\ \ and \ \ MedCity News\ \ • \ \ March 26, 2026\ \ June 14, 2024](/content/blog/from-recalls-to-reliability-tools-to-ensure-software-safety-in-medtech/index.html)
\ \ Product Updates\ Ketryx 2.7\ \ Erez Kaminski\ \ and \ \ • \ \ March 19, 2026\ \ June 3, 2024](/content/blog/ketryx-2-7/index.html)
\ \ Perspectives\ FDA Predetermined Change Control Plan (PCCP): Compliance Guide\ \ Lee Chickering\ \ and \ \ • \ \ March 26, 2026\ \ May 9, 2024](/content/blog/pccp-compliance/index.html)
\ \ In the News\ UL Certification: A Launchpad for Product Development Excellence\ \ Erez Kaminski\ \ and \ \ MedTech Intelligence\ \ • \ \ March 19, 2026\ \ May 1, 2024](/content/blog/ul-certification-a-launchpad-for-product-development-excellence/index.html)
\ \ Perspectives\ 21 CFR Part 11 Compliance Guide for Jira (Atlassian)\ \ Jake Stowe\ \ and \ \ • \ \ March 26, 2026\ \ April 12, 2024](/content/blog/21-cfr-part-11-compliance-guide-for-jira-atlassian/index.html)
\ \ Product Updates\ Ketryx 2.6\ \ Erez Kaminski\ \ and \ \ • \ \ March 19, 2026\ \ March 29, 2024](/content/blog/ketryx-2-6/index.html)
\ \ In the News\ Announcing Ketryx’s UL Certification to IEC 62304, ISO 13485, and ISO 14971\ \ Paul Jones\ \ and \ \ • \ \ March 19, 2026\ \ March 6, 2024](/content/blog/announcing-ketryxs-ul-certification/index.html)
\ \ Product Updates\ Ketryx 2.5\ \ Erez Kaminski\ \ and \ \ • \ \ March 19, 2026\ \ February 13, 2024](/content/blog/ketryx-2-5/index.html)
\ \ Perspectives\ MedTech Trends for 2024: Takeaways from JP Morgan's Health Conference\ \ Erez Kaminski\ \ and \ \ • \ \ March 19, 2026\ \ January 25, 2024](/content/blog/medtech-trends-for-2024-takeaways-from-jp-morgans-health-conference/index.html)
\ \ Perspectives\ $14M to Build the Future of Medical Software\ \ Erez Kaminski\ \ and \ \ • \ \ March 19, 2026\ \ December 5, 2023](/content/blog/14m-to-build-the-future-of-medical-software/index.html)
\ \ Perspectives\ IEC 62304 & Requirements Traceability Matrix (RTM) in Jira: A Guide for Medical Device Companies\ \ Jan Pöschko\ \ and \ \ • \ \ March 19, 2025\ \ November 13, 2023](/content/blog/iec-62304-requirements-traceability-matrix-rtm-in-jira-a-guide-for-medical-device-companies/index.html)
\ \ Perspectives\ How to generate an SBOM (Software Bill of Materials) fast\ \ Jan Pöschko\ \ and \ \ • \ \ March 26, 2026\ \ November 2, 2023](/content/blog/how-to-generate-an-sbom-software-bill-of-materials-fast/index.html)
\ \ Perspectives\ The latest (June 2023) changes to the FDA’s new premarket submission guidance\ \ Lee Chickering\ \ and \ \ • \ \ March 26, 2026\ \ October 16, 2023](/content/blog/the-latest-june-2023-changes-to-the-fdas-new-premarket-submission-guidance/index.html)
\ \ Academy\ Preparing for the PATCH Act and RTA\ \ MedTech Intelligence Staff\ \ and \ \ MedTech Intelligence\ \ • \ \ March 19, 2026\ \ September 27, 2023](/content/blog/preparing-for-the-patch-act-and-rta/index.html)
\ \ Perspectives\ The Turtle Problem\ \ Jake Stowe\ \ and \ \ • \ \ March 26, 2026\ \ September 12, 2023](/content/blog/the-turtle-problem/index.html)
\ \ Perspectives\ Simplifying 510K Submissions with FDA’s eSTAR Program and Ketryx\ \ Paul Jones\ \ and \ \ • \ \ March 26, 2026\ \ September 12, 2023](/content/blog/simplifying-510k-submissions-with-fdas-estar-program-and-ketryx/index.html)
\ \ Perspectives\ Best Practices for Maintaining a Requirement Traceability Matrix in Agile\ \ Jake Stowe\ \ and \ \ • \ \ March 19, 2026\ \ September 12, 2023](/content/blog/best-practices-for-maintaining-a-requirement-traceability-matrix-in-agile/index.html)
\ \ In the News\ Three steps for traceability in medical device software development quality and compliance\ \ Paul Jones\ \ and \ \ Medical Design and Outsourcing \ \ • \ \ February 11, 2025\ \ September 7, 2023](/content/blog/three-steps-for-traceability-in-medical-device-software-development-quality-and-compliance/index.html)
\ \ In the News\ Q&A: The facts about the PATCH Act\ \ Kiays Khalil\ \ and \ \ Medical Device Network \ \ • \ \ March 19, 2026\ \ September 4, 2023](/content/blog/q-a-the-facts-about-the-patch-act/index.html)
\ \ Perspectives\ Why the FDA’s Most Common Warning Letter Might Surprise You\ \ Erez Kaminski\ \ and \ \ • \ \ March 26, 2026\ \ August 24, 2023](/content/blog/why-the-fdas-most-common-warning-letter-might-surprise-you/index.html)
\ \ Perspectives\ PATCH Act: How to Comply in 2023 & Beyond\ \ John Koontz\ \ and \ \ • \ \ March 19, 2026\ \ August 16, 2023](/content/blog/patch-act-how-to-comply-in-2023-beyond/index.html)
\ \ Perspectives\ The Best RTM Tools for Agile Teams: Looking Beyond Excel\ \ Jake Stowe\ \ and \ \ • \ \ March 19, 2026\ \ August 9, 2023](/content/blog/the-best-rtm-tools-for-agile-teams-looking-beyond-excel/index.html)
\ \ Perspectives\ Clinical Trial Computerized Systems Regulation Review\ \ Jake Stowe\ \ and \ \ • \ \ March 26, 2026\ \ August 9, 2023](/content/blog/clinical-trial-computerized-systems-regulation-review/index.html)
\ \ Perspectives\ 2023 FDA Warning Letters and Software Validation\ \ Erez Kaminski\ \ and \ \ • \ \ March 26, 2026\ \ August 9, 2023](/content/blog/2023-fda-warning-letters-and-software-validation/index.html)
\ \ In the News\ AI Experts Network: Innovation Labs Series\ \ and \ \ AI Expert Network\ \ • \ \ February 11, 2025\ \ August 4, 2023](/content/blog/ai-experts-network-innovation-labs-series/index.html)
\ \ In the News\ Who pays the bills when AI kills?\ \ Erez Kaminski\ \ and \ \ The Hill\ \ • \ \ February 11, 2025\ \ July 20, 2023](/content/blog/who-pays-the-bills-when-ai-kills/index.html)
\ \ Academy\ FDA Cybersecurity SBOM Regulations and Compliance Guide\ \ Erez Kaminski\ \ and \ \ • \ \ March 26, 2026\ \ July 19, 2023](/content/blog/fda-drops-an-sbom/index.html)
\ \ Perspectives\ The Ultimate Guide to Requirements Traceability Matrix (RTM)\ \ Jake Stowe\ \ and \ \ • \ \ March 26, 2026\ \ June 19, 2023](/content/blog/the-ultimate-guide-to-requirements-traceability-matrix-rtm/index.html)
\ \ In the News\ How to Build Safer and More Reliable Software\ \ Erez Kaminski\ \ and \ \ builtin.com\ \ • \ \ March 19, 2026\ \ June 14, 2023](/content/blog/how-to-build-safer-and-more-reliable-software/index.html)
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