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 […]
Software Testing Is Not Hardware Testing Read More »
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
Newsletter V. 2019 Issue 1 Read More »
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
Embracing Change: Your Connected Medical Device is Never Finished Read More »
[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
FDA Software Guidances and the IEC 62304 Software Standard Read More »
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
Intro to Medical Device Software Read More »
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
Suggested Resources for Lean and Agile Product Development Read More »
“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.
Challenges Adopting Agile Methods for Medical Device Software Read More »
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
Medical Device Documentation Map Read More »
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
Accelerating Medical Device Development with Lean and Agile Methods Read More »
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
Accelerating Medical Device Development While Improving Compliance Read More »
