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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 - Quality Management and Corresponding General Aspects for Products with a Health Purpose Including Medical Devices
AAMI Staff Contact
Rachel Ann Porter
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