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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 02 - General Aspects Stemming from the Application of Quality Principles to Medical Devices Working Group
AAMI Staff Contact
Description
The AAMI QM/WG 02 General Aspects Stemming from the Application of Quality Principles to Medical Devices Working Group provides input into international standards developed by ISO/TC 210/WG 02 - General aspects stemming from the application of quality principles 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
- ANSI/AAMI/ISO 16142-1:2016, Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
- ANSI/AAMI/ISO 16142-2:2017, Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards