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Design Controls For The Medical Device Industry 3rd Edition 2020 at Meripustak

Design Controls For The Medical Device Industry 3rd Edition 2020 by Teixeira M B, Taylor & Francis Ltd

Books from same Author: Teixeira M B

Books from same Publisher: Taylor & Francis Ltd

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  • General Information  
    Author(s)Teixeira M B
    PublisherTaylor & Francis Ltd
    ISBN9780815365525
    Pages248
    BindingHardback
    LanguageEnglish
    Publish YearFebruary 2020

    Description

    Taylor & Francis Ltd Design Controls For The Medical Device Industry 3rd Edition 2020 by Teixeira M B

    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.