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So far tshafer has created 14 blog entries.

Newsletter V. 2018 Issue 2

FDA Software Guidances and the IEC 62304 Software Standard There are two sets of rules for SW regulation—twice the rules, twice the confusion. My recommendation is to base your software development procedures on the IEC 62304 Standard and then include any additional adjustments needed to meet all the FDA requirements. [...]

By |2018-12-04T09:29:01-08:00September 5th, 2018|News, Newsletters, V2018|0 Comments

On-time and under budget

Aaron Joseph helped Luma Therapeutics develop our quality system procedures and DHF documentation for the Luma Light System in 2017. This was in preparation for an FDA 510k filing. He came in on time and under budget for his services and was a valuable addition to the team. He has [...]

By |2019-11-20T12:18:47-08:00January 20th, 2018|News, Testimonials, V2018|0 Comments

Why Haven’t More Medical Device Companies Embraced Agile?

https://youtu.be/1mU2qo7GuT0 This short video provides an overview of Agile methods and an in-depth discussion of the practical considerations for satisfying regulatory requirements. A panel of three medical device professionals, with decades of experience across dozens of medical device companies, provide an in-depth overview of the practical realities of adopting Agile [...]

By |2019-03-06T07:13:11-08:00May 30th, 2017|Events, Lean & Agile, Videos|2 Comments
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