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 seminar:

* 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.