ISO 13485 as a Quality Management System for Medical Devices - Webinar By GlobalCompliancePanel

Venue: Online Training Webinar

Location: Wilmington, Delaware, United States

Event Date/Time: Dec 16, 2010 End Date/Time: Dec 16, 2010
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Description

ISO 13485:2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485:2003 will find themselves very closely compliant with FDA's Quality System Requirements under 21CFR 820.

Areas Covered in the Session:

* Principles of ISO 13485:2003
* ISO 9001 & ISO 13485 Differences
* Design Control
* Risk Management & ISO 14971
* MDD 93/42/EEC & Essential Requirements
* FDA’s MDR’s & EU Vigilance

Who Will Benefit:

* Regulatory Professionals
* Quality Engineers
* Manufacturing Engineers
* Operations Executives
* QA Managers

Venue

1000 N West Street | Suite 1200
Wilmington
Delaware
United States
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