Medical Device Design and Regulation

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ASQ Quality Press, 2011 - Business & Economics - 328 pages
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Contents

Background and Regulatory Environment
1
Medical Device Design
53
Nonclinical Testing and GLPs
79
Clinical Trials
99
Marketing Applications
143
PostMarket Requirements
213
Quality Systems and GMPs
247
Compliance and Enforcement
281
Website Links
293
Prohibited Acts
307
Index
315
Copyright

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