Newsletter V. 2026 Issue 1
November 2025 Newsletter – Building a firm foundation in risk management
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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?
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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2025 Season’s Greetings!
Happy Holidays! Wishing you and your business continued success and happiness this holiday season.
2025 Season’s Greetings! Read More »
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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Platform Approach to Managing Development of Medical Devices
“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?”
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Creating the Correct Design Control Phases
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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Newsletter V. 2025 Issue 3
September 2025 Newsletter – AI tools for Medical Device Development
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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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