2nd Edition
Validation for Medical Device and Diagnostic Manufacturers
336 Pages
by
CRC Press
336 Pages
by
CRC Press
Also available as eBook on:
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... Read more
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
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
Biography
Charmaine V. Sutton, Carol V. Desain
