Lecture : Clinical evaluation and evidence for medical devices ( view)
Greg LeBlanc ┃ Cook Medical270 views
About the Speaker
Regulatory Affairs and Quality Systems
A brief history
Greg is the Director of Regulatory Affairs and Quality Systems for Cook (Canada) Inc., a medical device importer and distributor for various Cook Group manufacturers worldwide.
He is responsible for all aspects of Canadian Regulatory Affairs for Cook Group along with maintaining Cook Canada’s Quality Systems certification.
Greg was the MedTech Canada (the Canadian Medical Device Industry Association – formerly MEDEC) representative on the Global Harmonization Task Force Study Group 5, where he served as Vice Chair. He continues to be active in various national and international regulatory initiatives, including serving as an Advisor to the Asian Harmonization Working Party Technical Committee and as a DITTA representative to the IMDRF Clinical Evidence Working Group. He also serves as the Chair of MedTech Canada’s Regulatory Committee and its International Regulatory Subcommittee.
Greg graduated from Queen’s University in Kingston, Ontario, Canada with a Bachelor’s Degree in Life Sciences and a Master’s Degree in Pharmacology.
He worked for several years in the pharmaceutical industry in the areas of Clinical Investigations, Medical Writing and Regulatory Affairs before making the transition to the world of medical devices with Cook more than 15 years ago.