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 01 - Application of Quality Systems to Medical Devices Working Group
AAMI Staff Contact
Rachel Ann Porter
Description
The AAMI QM/WG 01 Application of Quality Systems to Medical Devices Working Group provides input into international standards developed by ISO/TC 210/WG 01 - Application of quality systems 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 TIR102: 2019, US FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
- ISO 13485:2016, Medical Devices - A Practical Guide. Advice from ISO/TC 210
- ANSI/AAMI/ISO 13485: 2016, Medical devices - Quality management systems - Requirements for regulatory purposes
- ANSI/AAMI/IEC 62304: 62304:2006 & A1:2016, Medical device software - Software life cycle processes
- ANSI/AAMI/IEC 62304: 2006 & A1:2016 (Redline), Medical device software - Software life cycle processes