CREATE-BEST, MDII, & MDCC organized a workshop presenting a high level view of the Medical Devices product regulatory classification and a high level view of the registration process, for Canada, Europe and USA. This seminar presented how to build the documentation of the design and development process and meet the regulators expectations of the “Design Control” regulations.
Who is this for?
This seminar targeted students and young entrepreneurs interested in gaining advanced knowledge of the regulatory process and documentation to capture and structure the scientific/engineering information and facilitate their advancement toward commercialization.
Talk title: Regulatory Process Towards Commercialization of Scientific/Engineering Information
Where: University of Ottawa, SITE, room J0106
When: 5:30pm on Thursday Feb 23, 2017
Seminar slides: Slides, courtesy of Mr. Desmarais, can be downloaded form here.
About the speaker
Jean-Pierre is a visionary individual with more than 35 years of experience in the medical device industry. Serial entrepreneur with strong leadership qualities, milestone driven, led multidisciplinary teams with a proven track record in value creation by winning commercial and reimbursement approvals for complex cardiology and orthopaedic medical technologies.
President of Piramal Healthcare, Bio-Othopeadic Division, a company in the cartilage repair arena, he took over the company from a bankrupt stage, rebuilt the team and the science, obtain regulatory and reimbursement approval in EU, Canada, Australia and Asia, established the sales and marketing plans and created a sales team that led to the asset acquisition by Smith+ Nephew a world leader in Orthopedics. Prior to that, he held the function of Chief Scientific Officer at CryoCath Technologies, an Atrial Fibrillation novel technology, a start-up company that he joined in its early days until its acquisition by Medtronic. He played a major role in the strategic plan to harness the scientific and regulatory approvals inclusive of the US FDA. The company started with 8 employees and now employs more than 600 in the greater Montréal.
Strategic thinker in market product introduction to create commercial and scientific value, acquisition preparedness and asset sale. Jean-Pierre has served on several Boards of Directors: Biorthex (spine), CardiaNove (cardiac), BioSyntech (orthopedics) and recently Carré Technologies – Hexoskin (Connected Healthcare).
This event is organized by: