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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Accelerating Medical Device Development with Lean and Agile Methods

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

If you missed Aaron Joseph’s presentation on “Accelerating Medical Device Development with Lean and Agile Methods”, you can get the slides at http://www.slideshare.net/AaronJoseph7/lean-agile-feb2017patcaajosephss In his talk he shares how medical device companies can take advantage of lean and agile methods for speeding up hardware and software development if they understand how to adapt their quality system

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Modern Approach Document Files

Don’t Rely on Documents to Manage Your Documentation

Leave a Comment / Regulatory Compliance, Risk Management

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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video

Accelerating Medical Device Development While Improving Compliance

Leave a Comment / Events, Lean & Agile, Medical Device Development, Software Development, Videos

If you missed Aaron Joseph’s talk “Accelerating Medical Device Development While Improving Compliance”, the material is available as a video. He explores how to accelerate medical device development with lean and agile methods. Companies in multiple industries have found that lean and agile methods speed up their product development while simultaneously improving quality and cutting

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