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ISO 9001 & ISO 13485/88
In the United States, many leading medical device manufacturer have transformed their operations from being in compliance with Quality System Regulations (QSRs).


Although there is no regulatory requirement for ISO 9000 certification for medical device manufacturers, the latest draft of the QSRs by the FDA embraces many of the requirements of the ISO 9001 and ISO 13485/8 series of standards. Europe, Canada, Japan, and the United States are participating in a Global Harmonization Effort.