Is your company prepared for ISO13485:2003 ?

Transition Planning Workshop

Purpose:

The aim of this workshop is to provide information, recommendations for achieving consistent timing in the application of ISO 13485:2003 around the world. This workshop is intended for current and potential users of ISO 13485: 1996, and ISO 13488: 1996, those who are intending to use ISO 13485:2003.

ISO 13485:2003 is revised stand alone standard, it will specify the quality management system requirements for regulatory purposes for medical devices, biomaterials, biotechnologies and other related health technologies.

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

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

Who Should Attend?

Quality, Regulatory, R&D professionals, Executives, Managers, Management Representative, Engineers, Technologist, Consultants, Auditors who involved currently in or contemplating transition from ISO 13485:1996 or ISO 13485:1998 to ISO13485:2003 who are manufacturers, distributors, importers, in medical technologies should be attended.

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

Duration: 1 day

Prerequisites:

ISO 13485:1996, ISO 13488:1996,

ISO 9001:1994, ISO 9002:1994

Fee: $ 550 CAN

( Workshop is limited for 15 people, call for registration,tel:514-993 6542)

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