Devine Guidance for Complying with Japan's Quality System Regulation: MHLW Ministerial Ordinance 169 (Paperback) (ISBN-13: 9781490927770)

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 34-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 four books on quality and regulatory compliance: (a) Devine Guidance for Complying with the FDA's Quality System Regulation; (b) Devine Guidance for Complying with the European Medical Device Directive; (c) Devine Guidance for Complying with the European In-Vitro Diagnostic Directive; and (d) Devine Guidance for Complying with Japan's Quality System Regulation - MHLW Ministerial Ordinance 169. Prior to launching his commercial career, Dr. Devine served honorably as a member of the United States Marine Corps.