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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.
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