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35128 Conferences

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

Added by davidross759 on 2010-11-04

Conference Dates:

Start Date Start Date: 2010-12-16
Last Date Last Day: 2010-12-16

Conference Contact Info:

Contact Person Contact Person: Webinars
Email Email:
Address Address: Online Training, Wilmington, DE, 19801, United States
Phone Tel: 800-447-9407
Phone Fax: 302-288-6884

Conference Description:

Overview: This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements.

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
* FDAs MDRs & EU Vigilance

Who Will Benefit:

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