Find My Committee
As we manage the migration from Committee Central to AAMI StMP, committees will shift to the new platform in several phases in order to keep committee work flowing smoothly.
The lists below will be updated for each phase so that you can verify the current platform for each of your committees.
QM - WG 04 - Application of Risk Management to Medical Devices Working Group
AAMI Staff Contact
Rachel Ann Porter
Description
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.
Related Groups
Related Documents
- 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