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ISO 13485 as a Quality Management System for Medical Devices

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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.
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  • Added: June, 17th 2011
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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

Price:$245.00

Overview:


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
InstructorProfile:
requirements.
John Chapman

Regulatory Affairs
ISO 13485:2003 is a quality management system standard
Professional
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
l
Principles of ISO 13485:2003
been performed regulatory due

l
ISO 9001 & ISO 13485 Differences
diligence on over a dozen
l
Design Control
acquisitions in the past 12 years,
l
Risk Management & ISO 14971
exposing him to numerous quality
l
MDD 93/42/EEC & Essential Requirements
systems, including consent decrees
l
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
l
Regulatory Professionals
speaker at these meetings and the
l
Quality Engineers
annual RAPS conference. ...more
l
Manufacturing Engineers
l
Operations Executives
RelatedProducts
l
QA Managers
ISO 13485 Gap Analysis Toolkit
ISO 13485 Quality Manual


Intro to ISO 13485 Presentation
Materials
ISO 13485 Internal Auditor Checklist
more...
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