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Medical Product Quality Systems

A few decades ago, the FDA GMP requirements (a prescriptive set of laws) were used. Most other countries relied on these or on some similar subset of GMP's (Good Manufacturing Practices). The entire market was (for the most part) the United States of America. Today, there is a reliance on Quality Systems, and a global evolution towards one overall Quality System concept to meet the international market needs. The evolutionary factors leading to this 'harmonization' will be described and discussed.

Keywords:: ISO 13485:2003, ISO 9001:200, Regulations, FDA, Creative Commons, ISO 13485, OpenCourseWare, Medical Devices, GMP, GLP, GCP, ISO 9000, UCI, ISO 13, Quality Systems, EN 46001

Disciplines:

Business

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Material Type:: Online Course
Date Added to MERLOT:: January 7, 2009
Date Modified in MERLOT:: January 24, 2019
Author:: Unknown (Know the author?)
Submitter:: Larry Cooperman

Primary Audience:: Professional
Technical Format:: Website
Mobile Compatibility:: Not specified at this time
Language:: English
Cost Involved:: No
Source Code Available:: Yes
Accessibility Information Available:: Unknown
Creative Commons:: This work is licensed under a Attribution-NonCommercial-NoDerivs 3.0 United States