The CE Mark: Understanding the Medical Device Directive Review

Average Reviews:

(More customer reviews)This book mostly just reprints the CE regulations. It answered few of my questions, such as how to get a Product Certificate of Registration, etc.

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If your organization manufactures and exports medical devices to the European Union, you need to know about the CE Mark and how the Medical Device Directive will affect your organization. The European Union's Medical Device Directive is one of the EU's most frustrating and difficult-to-decipher mandates. Fortunately, author Les Schnoll has taken the mystery out of the directive for medical device manufacturers. Schnoll walks readers through the directive's numerous classes, articles, annexes and requirements. This book is a must read if you're exporting medical devices to the European Union.

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