AAMI Updates Quality System Compendium
November 27, 2007 // Published as a news service by IHS
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The Association for the Advancement of Medical Instrumentation (AAMI) updated The Quality System Compendium.
The publication is based on the U.S. Food and Drug Administration (FDA) quality system regulation and includes updated information for medical device professionals.
The revised version combines the first edition of The Quality System Compendium and the Supplement to The Quality System Compendium into one volume and provides updated information on regulatory areas that changed since both textbooks were published.
Updates include:
- New chapters on combination products and risk management for medical devices.
- An updated chapter on the FDA's organization and regulatory strategies including the recent reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA).
- Revised chapters on quality systems, design controls and process validation to reflect current FDA and industry thinking.
- A bibliography that includes references and web sites.
- A copy of the final rule for the quality system regulation including a list of all technical amendments published since 1996.
- An index.
Source: Association for the Advancement of Medical Instrumentation (AAMI).