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CRC Press Design Controls for the Medical Device Industry 3rd Ed

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Description

The third edition of Design Controls for the Medical Device Industry by CRC Press offers a comprehensive review of current design control requirements. This edition provides proven tools and techniques to help your company's design control program evolve alongside industry practices. It assists in building an effective program that satisfies the US FDA Quality Systems Regulation (QSR) and 13485:2016 standards. By following these guidelines, your organization can meet the expectations of FDA Investigators and Notified Body Auditors. The text covers essential design control elements including design planning, input, output, and review to ensure regulatory compliance and operational success.

Key Features

This third edition from CRC Press provides a comprehensive review of the latest design control requirements for medical device companies.

The text includes proven tools and techniques to help evolve a design control program in accordance with current industry practice.

Content is designed to satisfy both the US FDA Quality Systems Regulation (QSR) and the 13485:2016 standards.

The book helps meet the specific expectations of Notified Body Auditors and FDA Investigators.

Detailed reviews are provided for design control elements such as design planning, input, output, and review.

Product Specifications

Format
hardcover
Domain
Amazon UK
Release Date
20 August 2019
Listed Since
18 July 2018

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