ASQ Biomedical Division, Haggar Bruce (eds.) The Biomedical Quality Auditor Handbook

2nd edition. — Quality Press, 2013. — 293 p. — ISBN: 978-0873898362.This handbook serves as a reference source for the application of quality auditing principles to the biomedical industry, including coverage specifically pertaining to medical devices. The book focuses on the understanding of domestic and international concepts and principles of biomedical quality auditing, and includes information on related regulations, directives, standards, and guidance. The book covers a wide range of subjects that have specific interpretations unique to the biomedical industry. In addition to being a peerless reference for ASQ's Biomedical Auditor certification (CBA), this book is a valuable reference for biomedical professionals who want to execute better audits for medical devices and gain basic knowledge of biomedical technical areas and regulatory requirements.U.S. Base Law and Regulations
Base U.S. Law
U.S. Regulation
Labeling
Medical Device Reporting
Recalls
Establishment Registration and Listing
Device Tracking
Electronic Records and Signatures
In Vitro Diagnostic Product Guidance
Design Review Guidance
Risk Management Guidance
Quality System Inspection Technique
U.S. Compliance Programs for Medical Devices
Technical Knowledge
Sterilization
Biocompatibility
Controlled Environments and Utility Systems
Software
Laboratory Testing
Process Improvement Techniques
Reprocessing
International Standards and Guidance
International Quality System Guidance
The EU Medical Device Directives
International Auditing Guidelines
Common Medical Device Directives and Standards
International Regulations