Dr. Christopher J. Devine, the founder of DGII, has over 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 and writes a weekly blog for the Medical Device Summit, a weekly industry e-magazine. Prior to launching his commercial career, Dr. Devine served honorably in the United States Marine Corps.
Devine Guidance International, Inc. (DGII) was founded in March of 2011, by Dr. Christopher J. Devine, with the vision of creating a consulting firm that provides substantial value for medical device manufacturers by providing real solutions for day-to-day issues facing the industry. As the device industry grows increasingly complex, DGII provides solutions for resolving Quality Management Systems, Quality Control, and Regulatory Compliance issues.
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DGII is dedicated to ensuring our clients quality and regulatory compliance goals are achieved.
If you are in the device industry it is not a question of if the FDA will visit your facility for an inspection, it is a question of when will the FDA visit your facility? Is your organization prepared?