AAMI TIR97

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Principles for medical device security – Postmarket risk management for device manufacturers

Published by Publication Date Number of Pages
AAMI 09/27/2019 56
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AAMI TIR97 – Principles for medical device security – Postmarket risk management for device manufacturers

Provides guidance on methods to perform postmarket security risk management for a medical device in the context of the Safety Risk Management process required by ISO 14971. This TIR is intended to be used in conjunction with AAMI TIR57:2016.

Product Details

Published:
09/27/2019
ISBN(s):
9781570207259
Number of Pages:
56
File Size:
1 file , 1.3 MB
Note:
This product is unavailable in Russia, Ukraine, Belarus