Devine Guidance for Complying with the European Medical Device Directive (MDD): The MDD 93/42/EEC - Softcover

Devine, Dr. Christopher Joseph

Softcover

ISBN 10: 1468137581 ISBN 13: 9781468137583

Publisher: CreateSpace Independent Publishing Platform, 2012

Synopsis

The book dives into the fundamental requirements needed to be understood for device manufacturers to successfully introduce and market medical devices in the European Union (EU). Requirements for device entry into the EU differ significantly from the requirements defined by the US FDA.

About this title

About the Author:

Dr. Christopher Joseph Devine is the President of Devine Guidance International, Inc., a consulting firm specializing in providing solutions for regulatory compliance, quality, supplier management, and supply-chain issues facing the medical device industry. Previously, Dr. Devine spent 14-years with Boston Scientific, a Fortune 500 medical device manufacturer. Additionally, Dr. Devine is the author of Devine Guidance, a weekly blog focusing on the understanding of regulations mandated by the FDA and other regulatory bodies; and published by the Medical Device Summit, an e-magazine. Furthermore, Dr. Devine is a member of the editorial board of the Medical Device Summit. Dr. Devine has 33-years of experience in quality assurance, regulatory affairs, and program management. He is a senior member of the American Society of Quality (ASQ), a member of Regulatory Affairs Professionals Society (RAPS), a member of the Project Management Institute (PMI) and resides on several technical advisory boards. Dr. Devine received his doctorate from Northcentral University, with his doctoral dissertation entitled, “Exploring the Effectiveness of Defensive-Receiving Inspection for Medical Device Manufacturers: A Mixed-Method Study.” Dr. Devine also holds a graduate degree in organizational management (MAOM) and an undergraduate degree business management (BSBM). Prior to launching his professional career, Dr. Devine served honorably as a United States Marine.

About this edition

• Publisher: CreateSpace Independent Publishing Platform
• Publication date: 2012
• ISBN 10: 1468137581
• ISBN 13: 9781468137583
• Binding: Paperback
• Number of pages: 288