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September 16, 2016
A final draft for approval (FDIS) of “IEC 82304-1: Health software – Part 1: General requirements for product safety” has been circulated. The ballot ends on October 14, and the standard is expected to be published by the end of 2016. This standard applies to software products that do not require specific hardware designed for...
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AAMI TIR 57 on medical device cybersecurity risk management will be published in 2016.  Status: The TIR has been recognized by the FDA before it was even been made available for purchase by AAMI. The TIR is now available for purchase from AAMI.
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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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