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.
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
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