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Featured Resources

AAMI Training for Manufacturers

Industry Training for Medical Device Manufacturers

AAMI’s Education Profiles

AAMI/FDA Risk Management Summit

2015 Risk Management Summit Report (pdf)

Jan 9, 2019

13485: Medical devices—Quality management systems—Requirements for regulatory purposes, 3ed

Aug 3, 2018

Exploring Potential Revisions to ISO 14971 and ISO/TR 24971 (pdf)

Jul 9, 2018

Standards Spotlight: Preparation Begins as FDA Shifts Focus to Quality Management Systems Standard

May 10, 2018

FDA to Shift Focus to International Standard, Replacing Quality System Regulation

Apr 3, 2018

Standards Spotlight: FDA Considering Updates to Quality System Requirements

Mar 26, 2018

FDA Considering Updates to Quality System Requirements

Mar 5, 2018

The Quality System Compendium: CGMP Requirements and Industry Practice, Third Edition

Jan 2, 2018

Standards Spotlight: The Compliance Countdown Has Begun for 13485:2016

Nov 9, 2017

AAMI Quality Systems White Paper: Comparison of 21 CFR Part 820 to ISO 13485:2016 (pdf)

Oct 27, 2017

Standards Spotlight: New Standard Brings Quality Systems into Sterile Processing

Oct 27, 2017

An Integrated Nine-Step Approach to Managing Clinical Technology Risks

Aug 31, 2017

AAMI Publishes Risk Management 'How To' for Medical Device Startups

Jun 15, 2017

Risk in Healthcare Technology: How Do You Manage It Effectively?

Apr 10, 2017

Shifting Global Regulations to Hit Home for Medical Device Manufacturers

Jan 10, 2017

Major Risk Management Standard to be Updated

Feb 23, 2016

Quality and Risk Considerations for Health Information Technology (pdf)

Oct 29, 2015

Summit Expands Ownership of Risk Management

Mar 23, 2015

Eight Common Myths and Misunderstandings about Risk Management (pdf)