2014 - ISO 13485-an Effective Quality Management System

Instructor: John Chapman
Description:
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.
International interest in certified quality systems is increasing. Many foreign countries are now requesting medical device firms 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.
Objectives of the Presentation:
Principles of ISO 13485:2003
ISO 9001 & ISO 13485 Differences
Risk Management & ISO 14971
FDA's MDR's & EU Vigilance
Design Control
Changes Coming?
Who can Benefit:
Companies interested in understanding and implementing a quality management system that is universally accepted by regulatory authorities. Employees who will benefit include:
Quality & Regulatory Professionals
Quality System Auditors
Manufacturing & Design Engineers
Marketing Product Managers
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