Newsletter V. 2026 Issue 1
November 2025 Newsletter – Building a firm foundation in risk management
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Risk Management
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?
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
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Newsletter V. 2025 Issue 4
November 2025 Newsletter – Building a firm foundation in risk management
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Using a Hazards and Harms List to Improve Risk Management
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
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What’s Wrong with DFMEA?
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.
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The Big Picture for Medical Device Risk Management
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?
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Agile Design Controls Part 2 Webinar: Dynamic Risk Management for SW-Intensive Medical Devices
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
Medical Device Documentation Map
Compiling all of the DHF documentation for a new medical device can be confusing, even for experienced engineers. That’s why I created this “map” of document interdependencies. It’s a way to help explain graphically how the many documents fit together for a new product. Some key points in the map are: Risk analysis
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Don’t Rely on Documents to Manage Your Documentation
Medical device product development involves many design and testing challenges. It also involves the challenge of documentation—writing and managing hundreds or thousands of pages of compliance documentation. The traditional approach to this documentation challenge is to manage the product documentation simply as a set of documents, usually Microsoft Word or Excel files. Figure 1 illustrates
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