## The FDA Just Published Free Advice for Building With AI. Here's What Your Team Needs to Know.

Erez Kaminski  
and

April 20, 2026

The FDA AI warning letter is the clearest compliance signal the industry has seen. Teams that act on it now will have a two-year head start. Find out what the architecture looks like.

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## Navigating ISO 26262 and IEC 61508-3 Functional Safety Standards for Safety-Critical Software

Yashaswini Maregowda  
and

April 10, 2026

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## “Did We Catch Everything?” How Ketryx Turns Risk Management into Proactive Product Intelligence

Megan Mannino  
and

March 19, 2026

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## Why Change Impact Assessment Is the Hidden Bottleneck in Medical Device Development

Megan Mannino  
and

March 19, 2026

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## The VentureFizz Podcast with Erez Kaminski

Ketryx  
and   
VentureFizz  
and

March 19, 2026

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## Use of AI in imaging paves the way for other medical devices

Ketryx  
and   
Boston Business Journal  
and

March 19, 2026

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## As FDA moves builds out ‘Elsa,’ this AI compliance CEO underscores that need for a hybrid AI approach

Ketryx  
and   
R&D World  
and

March 19, 2026

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## Ketryx Wants Its Validated AI Agents To Accelerate Compliance Workflows

Shubham Singh  
and   
Citeline  
and

May 27, 2025

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## Achieve faster product releases with Ketryx's validated AI agents

Elizabeth Engler Modic  
and   
Today's Medical Developments  
and

May 2, 2025

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## AI Agents Launched to Streamline Compliance in Safety-Critical Sectors

Scarlett Evans  
and   
AI Business  
and

May 2, 2025

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## Ketryx AI Agents: How People and Agents Build Regulated Products Together

Erez Kaminski  
and

March 19, 2026

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## Ketryx’s New Integration with Azure DevOps (ADO): End-to-End Traceability for Regulated Teams

Milan Dzenovljanovic  
and

March 19, 2026

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## A Complete Guide to the FDA’s AI/ML Guidance for Medical Devices

Lee Chickering  
and

March 26, 2026

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## Navigating the FDA's New Draft Guidance on AI-Enabled Devices

Jenn Dixon  
and

March 26, 2026

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## Four Bold Predictions for Medtech in 2025: AI Everywhere, Faster Releases, and Rising Risks

Erez Kaminski  
and   
MPO News  
and

March 19, 2026

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## Three strategies for unlocking the power of continuous integration/continuous deployment (CI/CD) for AI-powered medical devices

Erez Kaminski  
and   
Medical Design & Outsourcing  
and

March 19, 2026

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## Why The Epidemic In Quality Failures And What MedTechs Can Learn

Erez Kaminski  
and   
Forbes  
and

March 19, 2026

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## Understanding FDA Guidance on AI in Medical Devices and Predetermined Change Control Plans (PCCPs)

Lee Chickering  
and

March 26, 2026

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## How to Survive FDA’s Predetermined Change Control Plan

Erez Kaminski  
and   
MD+DI  
and

March 19, 2026

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## Ketryx Tackles Software Safety in Medical Devices Amid Growing Recalls

Jenna Philpott  
and   
Medical Device Network  
and

March 26, 2026

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## MedTech Trends for 2024: Takeaways from JP Morgan's Health Conference

Erez Kaminski  
and

March 19, 2026

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## Clinical Trial Computerized Systems Regulation Review

Jake Stowe  
and

March 26, 2026

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## AI Experts Network: Innovation Labs Series

AI Expert Network

February 11, 2025

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## Who pays the bills when AI kills?

Erez Kaminski  
and   
The Hill  
and

February 11, 2025

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