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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
Language: en
Pages: 338
Authors: Amiram Daniel
Categories: Medical
Type: BOOK - Published: 2008-01-01 - Publisher: Quality Press

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How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and
The FDA and Worldwide Quality System Requirements Guide Book for Medical Devices
Language: en
Pages: 224
Authors: Kimberly A. Trautman
Categories: Business & Economics
Type: BOOK - Published: 1997 - Publisher: ASQ Quality Press

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This book provides essential information regarding the new FDA regulation for medical devices and international quality system requirements (ISO 9001 and ISO/DI
Medical Device Design and Regulation
Language: en
Pages: 369
Authors: Carl T. DeMarco
Categories: Business & Economics
Type: BOOK - Published: 2011-01-01 - Publisher: Quality Press

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Quality Risk Management in the FDA-Regulated Industry
Language: en
Pages: 293
Authors: Jose (Pepe) Rodriguez-Perez
Categories: Business & Economics
Type: BOOK - Published: 2024-04-18 - Publisher: Quality Press

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For quality professionals and manufacturers in the food safety and medical device industries, risk management is essential to ensuring organizations meet FDA re
Design of Biomedical Devices and Systems, 4th edition
Language: en
Pages: 543
Authors: Paul H. King
Categories: Technology & Engineering
Type: BOOK - Published: 2018-10-03 - Publisher: CRC Press

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This fourth edition is a substantial revision of a highly regarded text, intended for senior design capstone courses within departments of biomedical engineerin