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Featured Resources


Industry Training for Medical Device Manufacturers

AAMI/FDA Risk Management Summit

2015 Risk Management Summit Report (pdf)


11/9/2017

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

10/27/2017

Standards Spotlight: New Standard Brings Quality Systems into Sterile Processing

10/27/2017

An Integrated Nine-Step Approach to Managing Clinical Technology Risks

8/31/2017

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

6/15/2017

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

4/13/2017

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

4/10/2017

Shifting Global Regulations to Hit Home for Medical Device Manufacturers

1/10/2017

Major Risk Management Standard to be Updated

5/23/2016

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

2/23/2016

Quality and Risk Considerations for Health Information Technology (pdf)

10/29/2015

Summit Expands Ownership of Risk Management

3/23/2015

Eight Common Myths and Misunderstandings about Risk Management (pdf)