April 2017

Medical Device Software

Challenges Adopting Agile Methods for Medical Device Software

Leave a Comment / Lean & Agile, Medical Device Development, Regulatory Compliance, Software Development

“Agile” consists of a philosophy as well as multiple methods. The most well-known method and what most people associate with agile is the highly iterative scrum method, where scrum teams operate in 2-4 week sprints with daily meetings (scrums). Other agile methods are test-driven development, continuous integration, automated unit testing, planning poker, and pair programming. […]

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Medical Device Documentation Map

2 Comments / Medical Device Development, Regulatory Compliance, Requirements Management, Risk Management, Software Development, V&V Testing

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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