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The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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This second edition includes expanded and updated risk management information on healthcare products around the world. Before a biologic, pharmaceutical or medical device product can be approved and marketed, and throughout its lifecycle, the manufacturer must prove that any risk(s) associated with its use has been reduced as far as possible. This book includes information on, among other things: