Design Controls for the Medical Device Industry: 2nd Edition (e-Book) book cover

Design Controls for the Medical Device Industry

2nd Edition

By Marie B. Teixeira, Marie Teixeira, Richard Bradley

CRC Press

205 pages

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Description

The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company's design control program evolves in accordance with current industry practice. The text assists in the development of an effectiv

Table of Contents

Preface. Author Biography. Introduction. Device Classification. Overview of Design Controls. Design and Development Planning. Design Inputs Part I. Design Inputs Part II. Design Outputs. Design Review. Design Verification. Risk Management. Design Validation. Biocompatibility. Design Transfer. Design Change. Design History File. Quality System Inspection Technique. References. Appendices. Index.

About the Authors

Marie B. Teixeira is founder and principal consultant for QA/RA Compliance Connection, Inc., Odessa, Florida, USA. She holds a BS from University of Massachusetts Amherst, USA and is an American Society for Quality member, ASQ-certified quality manager and engineer, and RABQSA principle auditor. Previously she served as quality engineer at Raytheon, Norwood, Massachusetts, USA; GTE Government Systems, Needham Heights, Massachusetts, USA; and Sparton Electronics, Brooksville, Florida, USA; as well as director of quality assurance and regulatory affairs at Bioderm, Inc., Tampa Bay, Florida, USA and quality systems manager for regulatory affairs at Smith & Nephew, Largo, Florida, USA.

Subject Categories

BISAC Subject Codes/Headings:
MED009000
MEDICAL / Biotechnology
TEC021000
TECHNOLOGY & ENGINEERING / Material Science
TEC059000
TECHNOLOGY & ENGINEERING / Biomedical