Design Controls for the Medical Device Industry, Third Edition

Price: $235.00 - $106.87
(as of Mar 07, 2026 16:12:46 UTC – Details)

This third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company’s design control program evolves in accordance with current industry practice. It assists in the development of an effective design control program that not only satisfies the US FDA Quality Systems Regulation (QSR) and 13485:2016 standards, but also meets today’s Notified Body Auditors’ and FDA Investigators’ expectations.

The book includes a review of the 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. Practical advice, methods and appendixes are provided to assist with implementation of a compliant design control program and extensive references are provided for further study.

This third edition:

Examines new coverage of ISO 13485-2016 design control requirements

Explores proven techniques and methods for compliance

Contributes fresh templates for practical implementation

Provides updated chapters with additional details for greater understanding and compliance

Offers an easy to understand breakdown of design control requirements

Reference to MDSAP design control requirements
ASIN ‏ : ‎ B07VWYLPJ5
Publisher ‏ : ‎ CRC Press
Accessibility ‏ : ‎ Learn more
Publication date ‏ : ‎ August 2, 2019
Edition ‏ : ‎ 3rd
Language ‏ : ‎ English
File size ‏ : ‎ 7.2 MB
Enhanced typesetting ‏ : ‎ Not Enabled
X-Ray ‏ : ‎ Not Enabled
Word Wise ‏ : ‎ Not Enabled
Print length ‏ : ‎ 262 pages
Format ‏ : ‎ Print Replica
ISBN-13 ‏ : ‎ 978-1351261470
Page Flip ‏ : ‎ Not Enabled
Best Sellers Rank: #1,873,028 in Kindle Store (See Top 100 in Kindle Store) #78 in Medical Biotechnology #158 in Medical Technology (Kindle Store) #254 in Biomedical Engineering
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