Devine Guidance for Complying with Japan's Quality System Regulation: MHLW Ministerial Ordinance 169

by Christopher Jospeh Devine

Overview

The purpose of Dr. D's fourth book is to breakdown and analyze the requirements depicted in Ministerial Ordinance 169 (MO 169). The good news for the readers is that the Japanese regulation steals shamelessly from ISO 13485. If your organization has an approved ISO 13485 Quality Management System certificate, issued by a notified body, then compliance to MO 169 should be that proverbial cakewalk. However, there are some quirky nuances specific to doing business in Japan. In this book, the doctor will breakdown and provide guidance on the responsibilities of MHLW, PMDA, JPAL, JIS, and the MAH. Enough acronyms for you? Dr. D has also added some lessons in Japanese, while expanding on the importance of the Chief Impalable Officer (the Senior RA/QA individual) that will be required to fall on the sword if quality and regulatory issues arise. I hope you find value in this book as the doctor's intent is to not only teach but entertain as well. After all, books on quality and regulatory compliance are notoriously boring, so Dr. D has taken some liberty and injected some of his infamous dry humor into his fourth book.

Product Details

ISBN-13:	9781490927770
Publisher:	CreateSpace Publishing
Publication date:	07/05/2013
Series:	Devine Guidance , #4
Pages:	296
Product dimensions:	8.50(w) x 11.02(h) x 0.62(d)

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 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.