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Presented in Frankfurt, Germany - this course is now full
CMDCAS - Training
Using ISO 13485:2003
Recognized by Health Canada's Medical Devices Bureau
Although this course is full, you can still register so that you will have a priority for the next session in Europe.
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 Registrar participating in the CMDCAS, or by a Registrar who intends to participate in the CMDCAS.
PREREQUISITE
This course is designed for persons having a good understanding of the ISO 13485:2003.
OVERVIEW
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 20 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$ 1800
Cost includes the exam.
Session venue is the Dorint Taunus-Zentrum, near Frankfurt
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