ISO 13485 as a Quality Management System for Medical Devices

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Date:Wednesday, July 20, 2011
Time:10:00 AM PDT | 01:00 PM EDT
Live Webinar
Duration:60 Minutes
ISO 13485 as a Quality Management
System for Medical Devices



Register Now
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
John Chapman

Regulatory Affairs
ISO 13485:2003 is a quality management system standard
specially written for the medical device industry and is on the
John Chapman, BS, MBA, RAC has
U S Food & Drug Administration (FDA) list of recognized
over 30 years medical device
consensus standards. Medical device firms certified to ISO
regulatory experience and over 10
13485:2003 will find themselves very closely compliant with
years experience with the European
FDA's Quality System Requirements under 21CFR 820.
Union's medical device directive,
93/42/EEC. John has led two device
Areas Covered in the Session:
companies to ISO quality system
certification and CE marking. He has
Principles of ISO 13485:2003
been performed regulatory due

ISO 9001 & ISO 13485 Differences
diligence on over a dozen
Design Control
acquisitions in the past 12 years,
Risk Management & ISO 14971
exposing him to numerous quality
MDD 93/42/EEC & Essential Requirements
systems, including consent decrees
FDA's MDR's & EU Vigilance
as well as many notified bodies. He
earned his regulatory affairs
Click here to register for this webinar
certification (RAC) in 1998 and was a
contributing author to 2004
Who Will Benefit:
Fundamentals of EU Regulatory
Affairs, RAPS, 2004. He co-founded a
local RAPS chapter and has been a
Regulatory Professionals
speaker at these meetings and the
Quality Engineers
annual RAPS conference. ...more
Manufacturing Engineers
Operations Executives
QA Managers
ISO 13485 Gap Analysis Toolkit
ISO 13485 Quality Manual

Intro to ISO 13485 Presentation
ISO 13485 Internal Auditor Checklist
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