ISO 13485:2016: A Complete Guide to Quality Management in the Medical Device Industry, Second Edition

Descriptions

ISO 13485:2016: A Complete Guide to Quality Management in the Medical Device Industry, Second Edition By Itay Abuhav

Product Information:

• Format: Available in Kindle and Hardcover
• Publisher: CRC Press; 2nd edition (May 15, 2018)
• Publication Date: May 15, 2018
• Language: English
• ASIN: B07D2HV8LQ (Kindle), 1138039179 (Hardcover)
• ISBN-10: 1138039179
• ISBN-13: 978-1138039179
• Item Weight: 3.48 pounds
• Dimensions: 9.21 x 6.14 x 1.66 inches

Description:

• A comprehensive guide to understanding, interpreting, and implementing ISO 13485:2016 standard requirements in the medical device industry.
• Pragmatic and down-to-earth style with real-life examples and case studies from the author's consulting experience.
• Covers the identification of relevant requirements, harmonization with quality management systems, and the development of processes for design, development, product realization, and validation.

Pricing:

• Buy From Amazon Hard Cover:  $200.00+Additional costs of Shipping
• Buy Soft Copy from Booksbybb: $121.99 only

View Sample of the Book:

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• Once your payment is successfully received, you will be sent a confirmation email to the provided email address.
• In the email, you will find a link to access your e-books' on Google Drive.
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Author Information:

• Author: Itay Abuhav
• Experience: Over 15 years of consulting in quality management/control, specializing in the European medical device industry.
• Certifications: Highly qualified to certify organizations to ISO 9001 and ISO 13485.
• Websites: Active websites related to ISO 9001 and ISO 13485: www.9001quality.com and www.13485quality.com.

Editorial Reviews:

• The book is designed with a table of contents identical to the ISO standard for easy navigation and orientation.
• Real-life examples and case studies drawn from the author's extensive consulting experience.

Customer Reviews:

• Rating: 3.8 out of 5 (11 global ratings)
• Distribution: 51% 5-star, 19% 4-star, 12% 3-star, 0% 2-star, 19% 1-star.
• Top Review: Expresses concerns about the quality of the book binding.