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John Chapman
Instructor John Chapman
Product Id 600021
Duration 60 Minutes  
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

ISO 13485 as a Quality Management System for Medical Devices

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

Speaker Profile
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. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.

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