Medical Device Quality Management Software Systems

The Importance of Medical Device Quality Management Systems in FDA and ISO Environments

Manufacturers of finished medical devices made or sold in the United States must comply with GMP regulations enforced by the U.S. Food and Drug Administration (FDA). The Quality System Regulation or QSR (21 CFR 820) contains essential requirements that apply to medical device manufacturers, and it is the primary medical device regulation that the FDA enforces.

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