A Beginner’s Guide to Medical Device Risk Management Last updated: 6-APR-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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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
Common Errors in Medical Device Risk Management Read More »
November 2025 Newsletter – Building a firm foundation in risk management
Newsletter V. 2026 Issue 1 Read More »
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
When should V&V really start in medical device development? Read More »
I’ve helped many medical device development teams with formal risk assessment and I’m often asked, “Why do we need to do this?” This question doesn’t mean they don’t care about product safety. They just don’t see the value in the formal process and documentation. Compiling a documented risk assessment is difficult and time consuming. It
Why Do We Need Formal Risk Assessment? Read More »
Happy Holidays! Wishing you and your business continued success and happiness this holiday season.
2025 Season’s Greetings! Read More »
November 2025 Newsletter – Building a firm foundation in risk management
Newsletter V. 2025 Issue 4 Read More »
Compiling a Hazards and Harms List (HHL) at the beginning of medical device development is a simple technique to improve all risk management activities for that product (or family of products). Have you ever been in an audit trying to explain to the auditor why the severity of a particular harm is rated differently in
Using a Hazards and Harms List to Improve Risk Management Read More »
“Don’t depend on documents to manage your documentation!” Product teams developing a new medical device need to produce a lot of documentation but that doesn’t mean they should use the documents to manage all the product data, especially for software-intensive medical devices. “Are these the latest software requirements? Who has the latest draft test protocol?”
Platform Approach to Managing Development of Medical Devices Read More »
What are the correct design control phases for medical device development? To properly answer that question we have to step back and look at the bigger picture of product development processes and medical device regulations. There’s a simple answer to the question if we are only talking about your company and its quality system–the correct
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