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Global Medical Device Regulation
K3611.M45 G56 2012 in the Stamps Reading Room Core Collection
This book by the Regulatory Affairs Professionals Society (RAPS) is intended as a source of information on medical device regulations in the international arena, based largely on Global Harmonization Task Force and ISO requirements, and regulation s in the US, EU, Canada and Japan. It is both for those who are new to the field and experienced professionals working in multiple markets.