QM - Quality Management and Corresponding General Aspects for Products with a Health Purpose Including Medical Devices
AAMI Staff Contact
Primary Staff Contact: Amanda Benedict
Email: abenedict@aami.org
Description
The AAMI QM Quality Management and Corresponding General Aspects for Medical Devices Committee developed by ISO/TC 210 - Quality Management and Corresponding General Aspects for Medical Devices Committee, through the U.S. TAG to ISO/TC 210.
Related Groups
- QM/WG 01 - Application of Quality Systems to Medical Devices Working Group
- QM/WG 02 - General Aspects Stemming from the Application of Quality Principles to Medical Devices Working Group
- QM/WG 03 - Symbols & Nomenclature for Medical Devices Working Group
- QM/WG 04 - Application of Risk Management to Medical Devices Working Group
- QM/WG 06 - Application of post market surveillance systems to medical devices
Related Documents
- AAMI/IEC TIR60878: 2015, Graphical symbols for electrical equipment in medical practice
- AAMI/IEC TIR80002-1: 2009, Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
- ISO 13485: 2016 Handbook, Medical Devices - A Practical Guide. Advice from ISO/TC 210
- ANSI/AAMI/ISO 13485:2016, Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
- AAMI TIR102:2019, U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
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AAMI/ISO TIR24971: 2013/(R)2016, Medical devices - Guidance on the application of ISO 14971