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Session 6 Track 3 - New Realities: Cool Tools in Medical Devices
Session Chair(s)
Carolyne Desrosiers
Manager, Regulatory Projects
Lundbeck Canada Inc, Canada
The term medical device covers a vast range of equipment, from simple tongue depressors to haemodialysis machines. Like medicines and other health technologies, they are essential for patient care. On the global front, the International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonization and convergence. In Canada, the booming mobile app economy is quickly expanding into the health industry. There's a growing list of health-oriented apps and sensors that regular individuals can buy, from pedometers and heart-rate monitoring apps to general wellness-tracking apps. We're getting medically wired both at the professional and consumer end and the regulation of these medical devices is a vast and rapidly evolving field.
Speaker(s)
International Medical Device Regulations Forum - Update
Nancy Shadeed
Health Canada, Canada
Manager, International Affairs Division, Therapeutic Products Directorate
Software Regulated as a Medical Device
Colin Foster
Health Canada, Canada
Senior Regulatory Information Officer
Monitoring Your Health: There is no Place Like Home
Nicholas Zamora, MBA
TELUS Health, Canada
Chief Clinical Advisor
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