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CRC Press ISO 13485:2016 Guide - Medical Device Quality Management

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Description

Navigate the complexities of medical device quality management with this second edition guide from CRC Press. This comprehensive resource provides effective guidance for understanding, interpreting, and implementing ISO 13485:2016 standard requirements. Designed for maximum usability, the book features a table of contents that is identical to the ISO standard itself, allowing for quick navigation and orientation throughout the text. Written in a pragmatic and down-to-earth style, the author uses real-life examples and case studies drawn from years of professional consulting experience. This approach helps clarify even the most complex aspects of the ISO 13485:2016 standard. Whether you are managing compliance or implementing new quality processes, this guide serves as a practical tool for the medical device industry.

Key Features

This CRC Press guide provides practical instructions for implementing ISO 13485:2016 standard requirements within the medical device industry.

The book features a table of contents identical to the ISO standard to enable easy navigation and quick orientation for readers.

Real-life examples and case studies from years of consulting experience help illustrate complex regulatory requirements.

The second edition offers a pragmatic and down-to-earth tone designed to maximize usability for professionals in bioengineering and quality management.

This comprehensive resource covers extensive material to help users understand and interpret the ISO 13485:2016 standard effectively.

Product Specifications

Format
hardcover
Domain
Amazon UK
Release Date
15 May 2018
Listed Since
16 December 2017

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