CMDCAS - Training
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Thank you for providing an excellent course and thought provoking discussions on the Canadian Medical Devices Regulations. It was one of the most enjoyable training sessions I’ve attended in years.
Beverly G. Whitaker
Indigo Consulting Group, LLC |
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CMDCAS - Training
Recognized by Health Canada's Medical Devices Bureau
OBJECTIVES
This 2-day course aims at explaining the Canadian Medical Devices Regulations, the relationship between these regulations and ISO 13485, and the role and responsibilities of Registrars and auditors in an audit under the Canadian Medical Devices Conformity Assessment System (CMDCAS), as well as qualifying auditors that will support audit teams under CMDCAS.
WHO SHOULD ATTEND
This course is MANDATORY for auditors who will support audits of a QMS to ISO 13485 under the CMDCAS.
Attendance is limited to persons sponsored by a Registration Body participating in the CMDCAS, or by a Registration Body who intends to participate in the CMDCAS.
PREREQUISITE
This course is designed for persons having a good understanding of the ISO 13485:2003.
OUTLINE
The presentation will focus on:
the detailed contents of the Canadian Medical Devices Regulations,
an overview of the CMDCAS, including the role and responsibilities of Registrars and auditors, as well as what to look for in audits,
the links between ISO 13485 and the Canadian Medical Devices Regulations.
A 2-hour exam is available at the end of each session. Successful completion of this exam is a requirement for auditors supporting an audit team to ISO 13485 under CMDCAS. Writing of the exam is limited to qualified auditors and to auditors-in-training.
DETAILS
Groups are limited to a maximum of 16 participants for public sessions, and a priority is given to auditors. Contracts for in-house sessions are accepted, according to the availability of training personnel. Registrations to public sessions, and contracts for in-house sessions are taken on a "fisrt come - first served" basis.
In order for any in-house or public session to be given, a minimum number of participants is also required. Additional information is available by contacting Accademia Qualitas.
Each participant receives manuals which contains among other things the Regulations and the CMDCAS documents.
CREDITS
This course is recognized by Health Canada's Medical Devices Bureau for training auditors to the QMS requirements embedded in the Canadian Medical Devices Regulations.
DURATION
2 days.
CAD$ 1200
Cost includes the exam.
Taxes not included.
This course has been developed by, and is presented with Health Canada's Medical Devices Bureau.
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