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 ...
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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.
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