Design Controls for the Medical Device Industry, Third Edition

by Marie B Teixeira

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

262 pages, Kindle Edition

Published August 2, 2019

Reviews

[Vincent.Fang]

This book provides an in-depth exploration of the pivotal role of design controls in medical device development, particularly focusing on ensuring product safety, efficacy, and compliance while aligning with global regulatory requirements such as those from the FDA and ISO. It not only details the critical requirements for each phase—including design inputs, design outputs, verification, and validation—but also offers practical implementation methodologies and management strategies. These insights empower design and quality teams to effectively navigate complex regulatory challenges and maintain rigorous quality standards throughout the product lifecycle.