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This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, an
Regulatory Affairs for Biomaterials and Medical Devices
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Type: BOOK - Published: 2014-10-27 - Publisher: Elsevier

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All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. Thi
Medical Product Regulatory Affairs
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Authors: John J. Tobin
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Type: BOOK - Published: 2011-08-24 - Publisher: John Wiley & Sons

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Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceu
Regulatory Affairs in the Pharmaceutical Industry
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FDA Regulatory Affairs
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Pages: 401
Authors: David Mantus
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FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise