Software Development

Heart rate monitor wearable

Embracing Change: Your Connected Medical Device is Never Finished

1 Comment / Software Development, V2019

The proliferation of software in modern medical devices has enabled innovative new applications and many benefits to patients.  However, it has also created greater challenges for medical device companies: namely, managing greater product complexity and more reliance on third party software components.  For connected devices there are the added challenges of cybersecurity risks, protecting patient […]

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Processes of the IEC 62304 software standard

FDA Software Guidances and the IEC 62304 Software Standard

3 Comments / Lean & Agile, Regulatory Compliance, Software Development, V2018

[updated NOV 2023] “One approach to satisfy two sets of rules” for medical device software As stated in the last blog post, there are two sets of rules for medical device software—twice the rules, twice the confusion. My recommendation is to base your software development procedures on the international IEC 62304 standard, which is easier

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Suggested Resources for Lean and Agile Product Development

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

Here are some good online resources: http://www.leanprimer.com/downloads/lean_primer.pdf – good overview of lean principles written by two software management consultants (Craig Larman and Bas Vodde) who include aspects of software agile methods as well. http://theleanthinker.com/ – a blog by Mike Rother with lots of good observations and real-life issues involved in changing an organization to lean http://www.lean.org/ – Lean Enterprise

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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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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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