Devine Guidance - A compilation of Dr. D's Quality & Regulatory Articles from 2014: Volume 6 - Softcover

Devine, Dr. Christopher Joseph

Softcover

ISBN 10: 1517194393 ISBN 13: 9781517194390

Publisher: CreateSpace Independent Publishing Platform, 2015

Synopsis

This book dives primarily into the perils associated with medical device establishments that fail to comply with US FDA regulatory requirements. It dissects the specific regulatory issue and provides recommendations on how device establishments can comply with regulatory requirements. This is unlike most regulatory books written as Dr. Devine tells the story with an edge and some humor.

About this title

About the Author:

A well-known and respected medical device industry quality and regulatory expert, Dr. Christopher Joseph Devine is the president and founder of Devine Guidance International, Inc., (DGII) a consulting firm providing regulatory and quality compliance support for the medical device industry. Prior to launching DGII, Dr. Devine spent 14-years with Boston Scientific Corporation working in a variety of quality and regulatory management roles. Additionally, Dr. Devine is the author of Devine Guidance, a weekly blog focusing on quality and regulatory compliance issues facing the medical device industry; and published by the Medical Device Summit, an e-magazine. Furthermore, Dr. Devine has 35-years of combined experience in the fields of quality assurance and regulatory affairs; and is a senior member of the American Society of Quality (ASQ), a member of Regulatory Affairs Professionals Society (RAPS), a member of the Society of Manufacturing Engineers (SME), and a member of the Project Management Institute (PMI). 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. Finally, Dr. Devine is the author of five books on quality and regulatory compliance published by and available at Amazon.com. Prior to launching his commercial career, Dr. Devine served honorably as a member of the United States Marine Corps.

About this edition

• Publisher: CreateSpace Independent Publishing Platform
• Publication date: 2015
• ISBN 10: 1517194393
• ISBN 13: 9781517194390
• Binding: Paperback
• Edition number: 1
• Number of pages: 290