Design Controls, Risk Management & Process Validation for Medical Device Professionals

Design Controls, Risk Management & Process Validation for Medical Device Professionals

Book is in good condition! There is light wear from use. The pages are clean with no marks.

This handbook has been widely acclaimed as a best-selling publication and serves as the most current and comprehensive resource for the interpretation and comprehension of design controls. It is an indispensable guide, offering a thorough examination of FDA design controls for medical devices, encompassing all pertinent regulations and real-world illustrations. Comprising 440 pages measuring 8.5" x 11", this extensive manual provides a comprehensive analysis of FDA 21 CFR 820, cross-referenced with ISO 13485, to offer readers a profound and meticulous review of practical techniques for implementing design controls. It covers fundamental, intermediate, and advanced design control topics, making it an invaluable asset for the integration of new design control procedures or the enhancement of existing processes within medical device quality systems. Furthermore, this crucial resource precisely outlines key subjects, enabling quality managers and medical device developers to effectively enhance compliance and successfully navigate internal and external audits, as well as FDA inspections. The author provides a meticulous breakdown of the regulations, offering detailed interpretations supported by evidence from FDA design control guidance and the quality systems preamble. The inclusion of numerous examples, case studies, best practices, 70+ figures, and 45+ tables presents practical implementation techniques rooted in the extensive experience of the author in launching numerous medical device products and incorporating consultancy expertise from industry professionals. As an added benefit, purchasers of this handbook are granted access to downloadable and editable design control documents on the web. Additionally, bonus chapters delve into medical device classification, compliance with design controls, risk management, and the design control quality system preamble. Each major design control topic, namely Design and Development Planning, Design Input, Design Output, Design Transfer, Design Verification, Design Validation, Design Change, and Design History File, is allotted a dedicated section of 30 to 50 pages.

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