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Live Webinar

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ISO 13485 as a Quality Management System for Medical Devices

Date & Time: Thursday, February 16, 2012

10:00 AM PST | 01:00 PM EST

Duration: 60 Minutes

Instructor: John Chapman

Location: Online

Price : $245.00

 

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Instructor Profile:

Overview:

John Chapman Regulatory Affairs Professional

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: l l l l l l

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

John Chapman, BS, MBA, RAC has over 30 years medical device regulatory experience and over 10 years experience with the European Union's medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has been performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. ...more

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Regulatory Professionals Quality Engineers Manufacturing Engineers Operations Executives QA Managers

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ISO 13485 as a Quality Management System for Medical Devices  

This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and F...