Newsletter V. 2025 Issue 4
November 2025 Newsletter – Building a firm foundation in risk management
Newsletter V. 2025 Issue 4 Read More »
Risk Management
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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