Regulatory Compliance

What Are Medical Device Design Controls?

Medical device design controls are the regulations that govern the development of medical devices. The FDA established design controls in 1997 because they found that manufacturing controls alone were not sufficient. The FDA recognized that many patient injuries and deaths were the result of medical devices with fundamental design flaws (i.e. no matter how carefully …

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Invaluable for the team’s success

Aaron is excellent to work with and has been invaluable for the team’s success. His consistently identified issues and provided recommendations for resolving technical, process and regulatory challenges. Aaron is technically competent and is able to lead a cross functional group to resolution. Aaron is who I would call on to streamline technical or regulatory …

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FDA software guidances

FDA Software Guidances and the IEC 62304 Software Standard

“One approach to satisfy two sets of rules” for FDA software guidances As stated in the last blog post, there are two sets of rules for FDA software guidances—twice the rules, twice the confusion. My recommendation is to base your software development procedures on the IEC 62304 Standard, which is easier to understand, and then …

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Medical Device Software

Challenges Adopting Agile Methods for Medical Device Software

After more than 20 years, agile methods for software development are well-established, with extensive information and expertise available for anyone who wants to adopt them: https://www.agilealliance.org/ – Agile Alliance is a non-profit organization; good material for beginners (Agile 101) and many articles and links https://www.scrumalliance.org – Scrum Alliance is a non-profit organization; has many articles and links …

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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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Modern Approach Document Files

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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