QM - WG 04 - Application of Risk Management to Medical Devices Working Group
AAMI Staff Contact
Primary Staff Contact: Amanda Benedict
The AAMI QM/WG 04 - Application of Risk Management to Medical Devices Working Group provides input into international standards developed by ISO/TC 210 - IEC/SC 62A JWG1 - Application of risk management to medical devices, through the AAMI QM Committee which is the mirror committee and U.S. TAG to ISO/TC 210.
- AAMI/IEC TIR80002-1: 2009, Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
- AAMI/ISO TIR24971: 2013/(R)2016, Medical devices - Guidance on the application of ISO 14971
- AAMI/ISO TIR80002-2: 2017, Medical device software - Part 2: Validation of software for regulated processes
- ANSI/AAMI/ISO 14971:2019, Medical devices - Application of risk management to medical devices