Overview: 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.
Why should you attend: International interest in certified quality systems is increasing. A Many foreign countries are now requesting medical device firm's supply them proof of certification to ISO 13485:2003. To apply a CE mark under the Medical Device Directive, 93/42/EEC, certification to ISO 13485 is required in most cases. This presentation is an in-depth analysis of ISO 13485 with comparisons to ISAO 9001.
Areas Covered in the Session:
* 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:
* Manufacturing & Design Engineers
* Marketing Product Managers
* Quality System Auditors
* Quality & Regulatory Professionals
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
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.
Why should you attend: International interest in certified quality systems is increasing. A Many foreign countries are now requesting medical device firm's supply them proof of certification to ISO 13485:2003. To apply a CE mark under the Medical Device Directive, 93/42/EEC, certification to ISO 13485 is required in most cases. This presentation is an in-depth analysis of ISO 13485 with comparisons to ISAO 9001.
Areas Covered in the Session:
* 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:
* Manufacturing & Design Engineers
* Marketing Product Managers
* Quality System Auditors
* Quality & Regulatory Professionals
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
