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ISO 13485 as a Quality Management System for Medical Devices - Webinar By GlobalCompliancePanel
Dec 16,2010 - Dec 16,2010Online Training, Delaware, United States
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Highlights
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
- FDA’s MDR’s & EU Vigilance
- Regulatory Professionals
- Quality Engineers
- Manufacturing Engineers
- Operations Executives
- QA Managers
Event Reminder
- Registration Open
- Call for Papers
- Call for Speakers
- Receive GTM eblast updates
- Security Code:
Event Profile
- Speakers: John Chapman
- Attendees: Who Will Benefit: * Regulatory Professionals * Quality Engineers * Manufacturing Engineers * Operations Executives * QA Managers
Contact Details
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