Rules Are Changing for FDA Submissions for Software
Big news! After 16 years the FDA is changing its guidance on the software documentation needed in regulatory submissions.
Software Development
Documentation for Medical Device Software
The documentation needed for medical device software is lengthy and complex. This article provides a list of needed documentation and tips on the best way to manage it.
Accelerating Value Delivery for Medical Device Software
Erik Heuer describes his experiences accelerating medical device software development by bridging the gap between regulatory compliance and modern software development methods: incorporating DevOps concepts, leveraging documentation automation, and establishing the two wheels for innovation vs. development and deployment.
Intro to SaMD
SaMD, or Software as a Medical Device, is not just another mobile app. It is a new category of medical device that has particular regulatory considerations and is at the forefront of some of the most innovative new healthcare technology.
Software Testing Is Not Hardware Testing
Best practices for medical device HW testing are not best for SW testing Medical device development teams often ask me for help with software V&V. Even though they have their hardware development under control, these teams keep encountering software testing problems and the corresponding compliance documentation. Frequently, it’s because their company’s quality system, explicitly or …
Newsletter V. 2019 Issue 1
Embracing Change: Your Connected Medical Device is Never Finished Embracing change means setting up your organization, processes, and tools to efficiently manage changes during product development and after product launch. Agile Design Controls: Dynamic Risk Management for SW-Intensive Medical Devices Learn the nuts and bolts of how to integrate risk management into the overall product …
Embracing Change: Your Connected Medical Device is Never Finished
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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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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Intro to Medical Device Software
Beginner’s Guide to Medical Device Software “Medical Device Software for Newbies” or “Why is this stuff so confusing?” Many times I’m asked to explain to engineers how to manage compliance for medical device software development. From newcomers to experienced professionals, it remains a source of confusion and frustration. And a lot of the confusion comes …
Suggested Resources for Lean and Agile Product 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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