Medical devices

CMDCAS Training

In partnership with Health Canada

Developed in partnership with Health Canada, the training is centered on:

  • the contents of the Canadian Medical Devices Regulations (CMDR),
  • the details of the Canadian Medical Devices Conformity Assessment System (CMDCAS) and the roles and responsibilities of registrars (certification bodies) and auditors,
  • the links between ISO 13485:2003 and the CMDR.

A two-hour exam is administered at the end of the training session (in the afternoon of day 2). An attendee must pass the exam before being eligible to participate on an audit team using ISO 13485 in the context of the CMDCAS.

The fee to attend the Ottawa session is $1350 CAD + 13% local taxes. Please read the "Detail" section below to see what the fee covers.

Objective

This two-day training (including the exam) aims to explain the Canadian Medical Devices Regulations, the links between those regulations and ISO 13485, and the roles and responsibilities of registrars and auditors during audits in the context of the Canadian Medical Devices Conformity Assessment System (CMDCAS).

Finally, the training aims to qualify auditors who will support audit teams working in the context of the CMDCAS.

Target Audience

This course is mandatory for auditors supporting the audit of a QMS under ISO 13485 in the context of the CMDCAS.

Participants must be employed by, or sponsored by, a registrar participating in, or intending to participate in, the CMDCAS.

Registration can be done online once dates are available. Participation must be approved and confirmed by Accademia Qualitas and is generally on a first-come, first-served basis.

Prerequisites

This course is intended for persons having a good understanding of the ISO 13485:2003 standard.

Participants must be employed by, or sponsored by, a registrar participating in, or intending to participate in, the CMDCAS.

Duration

2 days (including exam)

Details

This training and certification was developed with, and is presented in partnership with, Health Canada / Santé Canada.

  • Public sessions are limited to 20 participants.
  • Registration can be done online once dates are available. Participation must be approved and confirmed by Accademia Qualitas and is generally on a first-come, first-served basis.
  • There must be a minimum number of participants registered in order to proceed with the training.
  • Internal training sessions are possible depending on the number of personnel that need to be trained, location and availability of the instructors.

The fee covers:

During a training session, each participant will receive:

  • CMDCAS Training - a manual with a copy of all the slides presented during the training, and extra space for taking notes.
  • CMDCAS Appendix - a second manual, containing copies of the Canadian Medical Devices Regulations, and other relevant documents or exerpts.
  • ISO 13485:2003 - on loan - for reference only, during the training session (must be returned at the end of the training).
  • A continental breakfast each morning, and a buffet lunch (with vegetarian options).
  • Three coffee/tea/water breaks during the two days.
  • The exam - which must be completed and returned in class in two hours or less (2½ hours if English is not the participant's mother tongue). The passing grade is 75%.
  • An electronic certificate of attendance for 12 hours of training.
  • If and when all requirements are met, an electronic CMDCAS certification document.

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