Introduction and overview of the Canadian Medical Devices Regulations
For manufacturers, importers and distributors of Medical Devices sold in Canada |
... I liked the webinar
format - it was very intuitive and easy to set up. The instructors seemed very knowledgeable about the subject mattter.
Bonniejean Boettcher
Neurometrix |
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Introduction and overview of the Canadian Medical Devices Regulations
For manufacturers, importers and distributors of Medical Devices sold in Canada
OBJECTIVES
Provide basic training on the Canadian Medical Devices Regulations, and the applicability of its various sections to manufacturers, importers and distributors.
WHO SHOULD ATTEND
This course is designed for managers at all levels in the manufacturer’s organization, as well as anyone wanting to discover the Canadian Regulations related to medical devices. Importers and distributors can also benefit from the course.
PREREQUISITE
No prerequisite, although knowledge of ISO 13485 would be useful for the second half of the course.
OVERVIEW
Applicability of the Food and Drugs Act (FDA)
Applicability of the Medical Devices Regulations (MDR)
Applicability of the CMDCAS
Classes of devices
Types of licences
Overview of the pre-market and post-market activities
ISO 13485 VS the MDR
Useful guidance documents from Health Canada
INSTRUCTORS
Francine Bouchard and Denis Pronovost will present the material and will answer questions. Francine has a vast experience as Quality Manager, consultant and auditor in the food, drugs and medical devices fields. Denis has experience in international standardization and auditor training, and is the author of books on auditing.
DETAILS
For information on the necessary equipment, or on the time zones, please go to the page on the technical aspects.
CREDITS
A certificate of attendance will be sent after the session.
DURATION
2 hours; please reserve an extra 30 minutes, just in case…
CAD$ 200
Attendance to virtual classes is limited for a more effective participation.
This course can be delivered whenever a minimum of 4 participants make a special request to that effect.
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