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Integrated Safety and Risk Assessment for Medical Devices and Combination Products
Language: en
Pages: 496
Authors: Shayne C. Gad
Categories: Medical
Type: BOOK - Published: 2020-02-24 - Publisher: Springer Nature

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While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotox
Safety Evaluation in the Development of Medical Devices and Combination Products
Language: en
Pages: 314
Authors: Shayne C. Gad
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Type: BOOK - Published: 2008-10-20 - Publisher: CRC Press

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Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety
Registries for Evaluating Patient Outcomes
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Pages: 385
Authors: Agency for Healthcare Research and Quality/AHRQ
Categories: Medical
Type: BOOK - Published: 2014-04-01 - Publisher: Government Printing Office

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This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase unders
Rare Diseases and Orphan Products
Language: en
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Authors: Institute of Medicine
Categories: Medical
Type: BOOK - Published: 2011-04-03 - Publisher: National Academies Press

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Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions i
Safety Evaluation in the Development of Medical Devices and Combination Products, Third Edition
Language: en
Pages: 0
Authors: Shayne C. Gad
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Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety