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Richard, Thanks for clarifying this question! -Steve- ------------------------------ Steve Rakitin Software Quality Consulting ------------------------------

Hi all, The Third Edition of the Medical Device Risk Management Standard ISO 14971 was recently released. Does anyone know if the EU will consider adopting this version or will they continue to require compliance with EN 14971 2012? It was expected that the third edition might incorporate some of ...

Hi everyone, if you are interested in learning how FDA and EU regulates medical device software, you may want to attend this two-day course presented by IEEE Boston April 10-11. Here is the link with all of the details.... Software Development for Medical Device Manufacturers: An intensive Two-day ...

As someone who has worked in the medical device industry for over 25 years, I was a bit leery when I heard about a documentary on the medical industry. However, after watching this film, I was genuinely shocked and very disappointed. "The Bleeding Edge" is documentary film about the medical device ...

Hi everyone, Just an FYI, MassMEDIC is sponsoring this two day course July31-Aug 1. It is intended to help provide understanding of what is required by FDA and EU for medical device software. Visit MassMEDIC website and click events for details... -Steve Rakitin