subject: ISO 13485 as a Quality Management System for Medical Devices - Webinar By GlobalCompliancePanel [print this page] ISO 13485 as a Quality Management System for Medical Devices - Webinar By GlobalCompliancePanel
Overview: 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.
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.
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
FDA's MDR's & EU Vigilance
Who Will Benefit:
Regulatory Professionals
Quality Engineers
Manufacturing Engineers
Operations Executives
QA Managers
Overview: 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.
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
FDA's MDR's & EU Vigilance
Who Will Benefit:
Regulatory Professionals
Quality Engineers
Manufacturing Engineers
Operations Executives
QA Managers
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