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.
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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