HeRo Seminar - Regulation of Medical Devices with Health Canada

Описание: Description:

Jade will be giving an overview on general regulation environment for medical devices in Canada. Greg will be speaking on the necessary technical evidence to demonstrate safety and effectiveness in a medical device application. Safety and effectiveness can be demonstrated through a number of avenues including conformity to safety standards, bench testing for accuracy, software testing, biocompatibility and sterilization testing, clinical evidence and literature studies.


Bios:
Jade Battou is an expert in Stakeholder Engagement of the Medical Devices Directorate of Health Canada. She holds a Master Degree in Biochemistry from Pierre & Marie Curie University in Paris. Jade joined the Medical Devices Directorate in 2016; she most recently led the COVID-19 regulatory team. Before that, Jade was the supervisor of the medical devices licensing section, responsible for managing licence applications, overseeing and coordinating regulatory activities with the various scientific review groups, in addition to developing SOPs, guidelines to ensure quality and efficiency of regulatory processes.

Besides her 4 years of experience within the Bureau of Licensing services, Jade has extensive experience in clinical research on human subjects and post-market surveillance of health products in both government and hospital settings.

Jade lives in Ottawa with her husband and their young kids.


Greg Jackson has a background in Electrical Engineering (University of Ottawa) and Clinical Engineering (University of Toronto). He previously worked with a surgical robotics distributor as a technical and clinical representative for the da Vinci surgical robotics platform at a number of hospitals across Ontario. After some time spent in Alberta as a data analyst and engineer for an energy exploration company, he returned to Ottawa and works as a Scientific Evaluator for the Digital Health Technologies division of the Medical Devices Directorate at Health Canada.


In his spare time, he enjoys reading, playing music, woodworking, and spending time with family.