Newsletter V. 2026 Issue 4
October2026 Newsletter – Does your quality system restrict best practices for software development?
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Risk Management
The Shocking Scale of V&V Requirements
When your device has 300โฆ 3,000โฆ or 12,000 requirements โ 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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Newsletter V. 2026 Issue 3
June 2026 Newsletter – AI for medical device development, compliance, regulatory, and quality operations
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Newsletter V. 2026 Issue 2
April 2026 – Better risk management for medical devices
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Medical Device Risk Management Starter Kit
A Beginner’s Guide to Medical Device Risk Management Last updated: 23-MAY-2026 Curated by:ย 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 โgoodโ looks like. This guide simplifies the starting point. It brings together
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Common Errors in Medical Device Risk Management
Common risk management mistakes and misconceptions Risk management is crucial to medical device development but thereโs still a lot of confusion about what it is and why we do it. Hereโs a list of the most common risk management mistakes and misconceptions Iโve encountered. Hopefully, greater awareness of these will help product teams and companies
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Newsletter V. 2026 Issue 1
February 2026 Newsletter – Practical Approaches for Risk Management and V&V
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When should V&V really start in medical device development?
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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Why Do We Need Formal Risk Assessment?
Iโve helped many medical device development teams with formal risk assessment and Iโm often asked, โWhy do we need to do this?โ This question doesnโt mean they donโt care about product safety. They just donโt see the value in the formal process and documentation. Compiling a documented risk assessment is difficult and time consuming. It
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Newsletter V. 2025 Issue 4
November 2025 Newsletter – Building a firm foundation in risk management
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