Beginner’s Guide to Medical Device Software “Medical Device Software for Newbies” or “Why is this stuff so confusing?” This article is designed for people who are new to medical device software—either experienced with software but not medical device regulations or experienced with medical device hardware only. Why is software special? References on medical cybersecurity for […]
Newsletter V. 2018 Issue 1 Read More »
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 a pleasant, relaxed demeanor, always
On-time and under budget Read More »
The successful market introduction of a medical device requires design verification and validation testing (V&V) (per 21 CFR 820.30 and ISO 13485 7.3). Even for experienced teams, V&V can be very challenging, requiring tight coordination of multiple activities and the correct execution of many preceding activities. I have worked on V&V testing for a wide
