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