A workshop with approximately 80 invited medical wireless experts was held in October 2012. This report, at the link provided, documents the discussion and outcomes of this workshop. A follow-up meeting is planned for March 2013. 2012_Wireless_Workshop_PublicationRead More
The total number of FDA software, computer system, and electronic records warning letters in 2012 is approximately 30 which is up from 18 in 2011 and fewer in 2009 and 2010. This is based on the keyword searches we perform on a regular basis but is not guaranteed to be comprehensive.Read More
Schedule Discussion with John F. Murray, Jr.
John is currently providing telephone and face-to-face meetings to discuss: Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.
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