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 […]
Medical Device Risk Management Starter Kit Read More »
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 »
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 »
Describes the shortcomings of using DFMEA as the first and only risk assessment tool for medical device risk management and recommended alternatives. Includes in-depth discussions by subject matter experts.
What’s Wrong with DFMEA? Read More »
Understanding all the details of risk analysis methods and compliance with the ISO 14971 risk management standard can be quite complicated but fundamentally, for development of a new medical device, risk management is about answering these seven key questions: What are all the possible things that could go wrong? What are we most worried about?
The Big Picture for Medical Device Risk Management Read More »
Agile Design Controls Part 2 Webinar: Dynamic Risk Management for SW-Intensive Medical Devices This webinar describes a dynamic approach to managing risk analysis and risk controls to keep up with fast moving product development teams. Learn the nuts and bolts of how to integrate risk management into the overall product development workflow using a requirements
