Devine Guidance for Complying with the European In-Vitro Diagnostic Directive (IVDD): The IVDD 98/79/EC

by Christopher Joseph Devine

Overview

The purpose of Dr. D's third book is to breakdown and analyze the requirements depicted in the 98/79/EC, also known as the European Directive on In Vitro Diagnostic Medical Devices (a.k.a. the IVDD). The doctor plans to tackle each of the Articles and Annexes sequentially and hopes the readers are able to glean some useful information while enjoying the common-sense, objective, and no-nonsense approach to complying with each of the requirements. The IVDD is somewhat of a quirky Directive when compared to its siblings, the AIMDD and the MDD. It is the doctor's hope that this book demystifies the often misinterpreted IVDD. For those of you that are frequent followers of Dr. D's weekly rants, posted in The Medical Device Summit, you will recognize the often poignant prose employed by Dr. D. That being said, I really hope you enjoy the book!

Product Details

ISBN-13:	9781478364955
Publisher:	CreateSpace Publishing
Publication date:	08/04/2012
Pages:	244
Product dimensions:	8.50(w) x 11.00(h) x 0.51(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. D 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 33-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 two books on quality and regulatory compliance; "Devine Guidance for Complying with the FDA's Quality System Regulation" and "Devine Guidance for Complying with the European Medical device Directive." Prior to his commercial career, Dr. Devine served honorably as a member of the United States Marine Corps.