2nd Edition

Validation for Medical Device and Diagnostic Manufacturers

    336 Pages
    by CRC Press

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    Implementation of FDA's Design Control requirements (21 CFR 820.30) changed an entire industry. Quality System Requirements defined the approach to medical device validation. Product design, manufacturing process, and test method validation studies must be performed before or as a product is transferred to commercial production. Validation studies must demonstrate that product design, process, and test methods/requirements/specifications determined during development can be met in the environment of intended use. This book provides practical guidance on how to develop and validate product designs, manufacturing processes, and test methods that comply with the requirements of QSR.

    Introduction to Quality Systems
    Validation Overview
    Product Development & Validation
    Validation Study Plans, Protocols, Reports
    Process Development & Validation
    Test Method Development & Validation
    Qualification of Equipment & Equipment Systems
    Qualification of Software-Driven, Automated Equipment & Equipment Systems
    Facility Qualification Studies
    Validation Studies at Suppliers & Contractors
    Change Management for Validated Products, Processes, & Methods
    Revalidation & Requalification Studies
    Supporting Appendices


    Charmaine V. Sutton, Carol V. Desain