ISO 13485 as a Quality Management System for Medical Devices
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 FDAâ€™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
- FDAâ€™s MDRâ€™s & EU Vigilance
Who Will Benefit:
- Regulatory Professionals
- Quality Engineers
- Manufacturing Engineers
- Operations Executives
- QA Managers