Design Controls for the Medical Device Industry: Edition 2

Marie B. Teixeira · Marie Teixeira · Richard Bradley

2013年11月 · CRC Press

關於本電子書

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

關於作者

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.