Design Controls for the Medical Device Industry (Hardcover, 2nd New edition)

The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company's design control program evolves in accordance with current industry practice. The text assists in the development of an effective design control program that not only satisfies the US FDA Quality System Regulation (QSR) and ISO 9001 and 13485 standards, but also meets today's third-party auditor/investigator expectations and saves you valuable time and money. The author's continual participation in FDA QSR inspections and Notified Body ISO audits is reflected in updates to all chapters and appendices of the book, now bursting at the seams with: New coverage of ISO 9001 and 13485 design control requirements More real-world examples from the medical device industry Additional detail for greater understanding and clarity Fresh templates for practical implementation Extensive references for further study The book addresses design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe.

General

Imprint:	Crc Press
Country of origin:	United States
Release date:	November 2013
First published:	2014
Authors:	Marie B. Teixeira
Dimensions:	235 x 156 x 21mm (L x W x T)
Format:	Hardcover
Pages:	205
Edition:	2nd New edition
ISBN-13:	978-1-4665-0354-0
Categories:	Books > Medicine > General issues > Medical equipment & techniques > General Books > Professional & Technical > Technology: general issues > Instruments & instrumentation engineering > General Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Other manufacturing technologies > Precision instruments manufacture > General
LSN:	1-4665-0354-8
Barcode:	9781466503540

Is the information for this product incomplete, wrong or inappropriate? Let us know about it.

Does this product have an incorrect or missing image? Send us a new image.

Is this product missing categories? Add more categories.

Review This Product

No reviews yet - be the first to create one!