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. 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.
Areas Covered in the Webinar:
- Principles of ISO 13485:2003.
- ISO 9001 & ISO 13485 Differences.
- Risk Management & ISO 14971.
- FDA’s MDR’s & EU Vigilance.
- Design Control.
- MDD 93/42/EEC & Essential Requirements.
Who Will Benefit:
Companies interested in understanding and implementing a quality management system that is universally accepted by regulatory authorities.Employees who will benefit include:- Quality & Regulatory Professionals
- Quality System Auditors
- Manufacturing & Design Engineers
- Marketing Product Managers
Course Provider
John Chapman,
