Attention to persons responsible for regulatory affairs and quality systems.

Is your company prepared for ISO13485:2003 ?

Transition Planning Workshop

Purpose:
The aim of this workshop is to provide information and recommendations for meeting the target date in the application of ISO 13485:2003 worldwide. This workshop is intended for current and potential users of ISO 13485: 1996, ISO 13488: 1996 and those who intend to use ISO 13485:2003.

ISO 13485:2003 is a revised stand alone standard. It specifies the quality management system requirements for regulatory purposes as applied to medical devices, biomaterials, biotechnologies and other related health technologies.

The main objective of this workshop is to provide participants with the final release of the National mandatory standard ISO 13485:2003 as well as its major impact on a company's quality management system and regulatory affairs.

Industry should be aware that ISO 13485:2003 may be used for regulatory purposes when it is adopted into a national regulatory program for each country.

Who Should Attend?
Quality and Regulatory Affairs personnel, R&D professionals, Executives, Managers, Management Representatives, Engineers, Technologists, Consultants, Auditors who are involved currently or contemplating transition from ISO 13485:1996 or ISO 13485:1998 to ISO13485: 2003. Manufacturers, distributors and importers of medical technologies should also attend.

This workshop will be given by a member of Technical Committee 210 /CAC/SCC that recently released the Canadian National Standard ISO 13485:2003.

Fee: $ 550 CAN

Workshop is limited for 15 people. For registration: (514)-993-6542