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A Brief Background on Quality Systems for Medical Device Manufacturers

In 1993, the European Union published a new regulation requiring the establishing of a Quality System for most medical device manufacturers.  Demonstrating conformance with the regulation, called the Medical Devices Directive, led to CE Marking and unobstructed access into Europe.  The regulation was based on ISO 9000, the international standard for quality systems.

In 1996, the US FDA substantially revised the Good Manufacturing Practices (cGMPs) for
medical device manufacturers.  The new regulation, known as the Quality System regulation (QSr), published as 21 CFR 820, included virtually all of the ISO 9001 standard requirements with the exception of Contract Review.  Probably the most significant change for manufacturers was the inclusion of Design Control requirements.  In a global chain reaction, Canada, Japan, and recently several nations of Asia and Latin America have all embraced ISO 9000 requirements in regulations for medical device manufacturers.

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