𝑺𝒄𝒂𝒍𝒆 𝒐𝒇 𝑽&𝑽 𝑹𝒆𝒒𝒖𝒊𝒓𝒆𝒎𝒆𝒏𝒕𝒔

The Shocking Scale of V&V Requirements

Leave a Comment / News, Risk Management, V&V Testing, V2026, Videos

When your device has 300… 3,000… or 12,000 requirements — Verification & Validation has reached an entirely new scale. In this clip, Aaron Joseph talks about one of the most critical (and often underestimated) elements of medical device development: traceability.  In highly complex systems like surgical robotics, without clear requirement-to-test traceability, even great engineering looks

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Risk Management Starter Kit - a beginner's guide to medical device risk management and the ISO 14971 standard

Medical Device Risk Management Starter Kit

Leave a Comment / Risk Management, Training, V2026

A Beginner’s Guide to Medical Device Risk Management Last updated: 23-MAY-2026 Curated by:  Nishitha Cherukuri, Sharanya Kumar, Aaron Joseph Introduction Medical device risk management can feel overwhelming when you first encounter it. There are formal standards, dense terminology, and strong opinions about what “good” looks like. This guide simplifies the starting point. It brings together

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Misadventures in medical device risk management

Common Errors in Medical Device Risk Management

Leave a Comment / Risk Management, V2026

Common risk management mistakes and misconceptions Risk management is crucial to medical device development but there’s still a lot of confusion about what it is and why we do it. Here’s a list of the most common risk management mistakes and misconceptions I’ve encountered. Hopefully, greater awareness of these will help product teams and companies

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Development Stages

When should V&V really start in medical device development?

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V&V is traditionally viewed as the final phase of medical device development, but successful teams begin preparing for it from the start. While formal, documented Verification & Validation occurs at the end to demonstrate compliance, effective development integrates testing throughout. This includes developing test methods, building tools, and evaluating prototypes early and often. Waiting until

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