QM/WG 01 - Application of Quality Systems to Medical Devices Working Group
AAMI Staff Contact
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.
- 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