ISO 13485 as a Quality Management System for Medical Devices - Webinar By GlobalCompliancePanel 2010

  • 16 Dec 2010
  • Webinar

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
  • FDA s MDR s & EU Vigilance
Who Will Benefit:
  • Regulatory Professionals
  • Quality Engineers
  • Manufacturing Engineers
  • Operations Executives
  • QA Managers

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Important

Please, check "ISO 13485 as a Quality Management System for Medical Devices - Webinar By GlobalCompliancePanel" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Operations, Quality assurance
Education: Training

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