MIF Lunch & Learn 7: Getting your medical device approved
Many MIF projects are medical devices, with the potential to dramatically improve diagnostics and treatments. But medical devices are strictly regulated; Canada has one of the world's most stringent regimes for the approval of these devices. And while there are some similarities with the US approval process, there are key dinfferences that companies should consider before approaching that market. To help us understand these issues, we have assembled the following panel of experts:
Florent Chandelier is Chief Technology Officer for Imagia Cybernetics Inc in Montreal which focuses on the application of Artificial Intelligence to cancer detection and diagnosis. He is also co-founder of Cadens Medical Imaging where he managed strategic alliances and the development of innovative and market-driven products, including navigating critical regulatory concerns.
Tony Falco is a researcher and serial entrepreneur with a specialty in medical imaging. A holder of dozens of international patents, he has worked to obtain regulatory approvals in markets around the world, inclduing in the US and Canada. He is a frequent contributor to the MIF.
Danny Kroo is the founder of Docusys Corporation, which provides provides quality management and regulatory affairs consulting to medical device, aerospace, and industrial companies. He founded the company in 1994 and has since worked with hundreds of firms to help them obtain approvals for their technologies.
Xining Chen is a Regulatory Affairs and Quality Management Intern at Docusys Corporation, and holds a PhD in Materials Science. She is a frequent competitor in business competitions, including the Dobson cup, the Â鶹AV Bicentennial Student Sustainability Challenge and the HackMedTech.Â
