Design Controls for the Medical Device Industry

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Design Controls for the Medical Device Industry - Teixeira, Marie B.
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"Design control is a key element of a company's quality management system and is mandated by the U.S. FDA's Quality System Regulation under article 820.30 for most medical devices. Medical device companies wishing to comply with ISO 13485 to meet international requirements are also subject to design control requirements. This second edition of a bestselling book expands and updates all chapters with detail on current design control requirements, more examples, and further explanation and clarification of the requirements. ...

Design Controls for the Medical Device Industry 2017, CRC Press, London

ISBN-13: 9781138073715

2nd New edition

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Design Controls for the Medical Device Industry 2013, CRC Press

ISBN-13: 9781466503540

2nd edition

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Design Controls for the Medical Device Industry 2002, CRC Press, New York, NY

ISBN-13: 9780824708306

Hardcover

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