Understanding ISO 13485 vs. ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel

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