Design Controls, Risk Management & Process Validation for Medical Device Professionals: A Comprehensive Handbook for Interpreting and Implementing Design Control Regulation

Geckler, Mr. Vernon M

ISBN 10: 0692835415 / ISBN 13: 9780692835418

Editore: Design Controls, Risk Management, 2017

Good condition paperback. Pages are clean and unmarked. Spine is straight and uncreased. BOOK ONLY NO ACCESS CODES OR CDS Tulsa's largest used bookstore. Located on South Mingo Road since 1991. No-hassle return policy if not completely satisfied. Codice articolo mon0000365732

Riassunto:

This handbook is the most exhaustive resource ever written about FDA design controls for medical devices with a collection of all applicable regulations and real-world examples. Four-hundred & forty, 8.5" X 11" pages provides an extensive evaluation of FDA 21 CFR 820 and is cross-referenced with ISO 13485 to provide readers with a broad and in depth review of practical design control implementation techniques. This handbook also covers basic, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading existing process into medical device quality systems. This critical resource also specifically outlines key topics which will allow quality managers and medical device developers to improve compliance quickly to pass internal and external audits and FDA inspections. The author breaks down the regulation line by line and provides a detailed interpretation by using supportive evidence from the FDA design control guidance and the quality systems preamble. Numerous examples, case studies, best practices, 70+ figures and 45+ tables provide practical implementation techniques which are based on the author's extensive experience launching numerous medical device products and by integrating industry consultant expertise. As an added bonus, web access to downloadable and editable design control documents are included with this purchase. In addition, bonus chapters include: explanation of medical device classification, compliance to design controls, risk management, and the design control quality system preamble. 30-50 pages are dedicated to each of the major design control topics: Design and Development Planning, Design Input, Design Output, Design Transfer, Design Verification, Design Validation, Design Change and Design History File.

Dati bibliografici

Titolo: Design Controls, Risk Management & Process ...
Casa editrice: Design Controls, Risk Management
Data di pubblicazione: 2017
Legatura: paperback
Condizione: Good