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.\ \
Filter articles
Checking your Browser…
Verifying...
Stuck? Troubleshoot
Success!
Verification failed
Verification expired
Verification expired
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
Traceability to Automated Tests
\ \ In the News\ Former Medtronic CEO Joins Ketryx Board\ \ Medical Product Outsoucring \ \ and \ \ Medical Product Outsourcing\ \ • \ \ June 25, 2026\ \ June 25, 2026](/content/blog/former-medtronic-ceo-joins-ketryx-board/index.html)
\ \ In the News\ Ex-Medtronic CEO Bill Hawkins joins Ketryx board\ \ Medical Design & Outsourcing \ \ and \ \ Medical Design & Outsourcing \ \ • \ \ June 25, 2026\ \ June 25, 2026](/content/blog/ex-medtronic-ceo-bill-hawkins-joins-ketryx-board/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)
\ \ AI/ML\ The FDA Just Published Free Advice for Building With AI. Here's What Your Team Needs to Know.\ \ Erez Kaminski\ \ and \ \ • \ \ May 8, 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)
\ \ AI/ML\ The Compliance Confidence Trap: What 100 Requirements Reviews Still Miss\ \ Megan Mannino\ \ and \ \ • \ \ March 20, 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)
\ \ AI/ML\ “Did We Catch Everything?” How Ketryx Turns Risk Management into Proactive Product Intelligence\ \ Megan Mannino\ \ and \ \ • \ \ March 19, 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)
\ \ AI/ML\ AI-Assisted Change Impact Assessment: How 9 Engineers Doubled Their Completeness in Half the Time\ \ Megan Mannino\ \ and \ \ • \ \ March 19, 2026\ \ March 3, 2026](/content/blog/ai-assisted-change-impact-assessment-how-9-engineers-doubled-their-completeness-in-half-the-time/index.html)
\ \ Traceability\ Why Change Impact Assessment Is the Hidden Bottleneck in Medical Device Development\ \ Megan Mannino\ \ and \ \ • \ \ March 19, 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)
\ \ AI/ML\ The VentureFizz Podcast with Erez Kaminski\ \ Ketryx\ \ and \ \ VentureFizz\ \ • \ \ March 19, 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)
\ \ News video\ Spreadsheet Errors: The Hidden Risk In MedTech\ \ Erez Kaminski\ \ and \ \ Forbes\ \ • \ \ March 19, 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 Announcements\ New Integrations with Jama, Polarion, ADO, and TestRail Streamline Medical Product Development\ \ Milan Dzenovljanovic\ \ and \ \ • \ \ March 19, 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 Announcements\ Introducing Ketryx Intelligence: Accelerate Product Development Safely with Generative AI\ \ Erez Kaminski\ \ and \ \ • \ \ March 19, 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)
Sorry, no results for this filter combination. Reset filters.
Are You Building Medical Software?
Get started building software in minutes, not months.
.png)
Chat Widget