ISO 13485 as a Quality Management System for Medical Devices - Webinar By GlobalCompliancePanel

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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