Course code RA5

CMDR & CMDCAS, Canadian Medical Device Regulations & Canadian Medical Devices Conformity Assessment System

( half a day)

Course description:

This short course covers the specific regulatory requirements of the Canadian MDR, which any medical device manufacturer wishing to export to Canada must be in a position to fulfill. The Canadian “Medical Device Regulation” act of 1998 is reviewed in detail and its relationship to the EU MDD and FDA/QSR is discussed. Since January 1 st 2003, the Canadian Medical Devices Conformity Assessment System (CMDCAS) requires the mandatory audit of the medical device manufacturer’s Quality Management System against ISO 13485 in the context of the CMDR; this feature is explained. Participants will be provided with a list of organizations, which are currently accredited to audit EU medical device manufacturers according to CMDCAS.

Case studies are used to illustrate the various aspects of the CMDCAS.

Course objectives:

• To provide participants with a thorough understanding of the regulatory requirements of CMDCAS
• To show participants the relationship between the Canadian MDR, European MDD and American FDA/QSR.
• To demonstrate to participants the correlation of CMDCAS with ISO 13485

Who should attend:

The course is aimed at:

• Medical Device Manufacturers seeking entrance to the Canadian market:
• QA/RA Managers
• Sales, Marketing Personnel
• Internal Auditors

Course materials:

Participants will receive a comprehensive course manual with reference materials, and a certificate of attendance upon successful completion of the course.

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