Transitioning
to ISO 13485:2003
Join
us for a 1-1/2 hour overview discussing the ISO 13485:2003 quality system
for medical devices. This session will provide information and guidance
to medical device organizations pertaining to changes in quality management
systems necessary to comply with the U.S. Quality System Regulation,
the ISO 9001:2000 generic quality system standard, and the ISO 13485
quality system standard for medical devices.
Provided
in a concise format, this webinar is designed for specialists that have
preexisting experience with Quality Management System and Regulatory
functions, updating them on standard changes and preparing them to transition
to the new ISO 13485:2003 standard.
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Discussion
of changes in the ISO 13485 quality management system standard for
medical device organizations.
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The
standing of ISO 13485 within the various countries and regions that
regulate medical devices, including the US, Canada and Europe.
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The
general relationship of ISO 13485 to the ISO 9001 generic quality
management system standard and the US Quality System Regulation.
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A
section-by-section analysis of changes and their significance in relation
to ISO 13485:2003, ISO 9001:2000, and the Quality System Regulation.
Who
should attend?
Professionals involved in implementing, maintaining and auditing quality
management systems in a medical devices manufacturing environment.
Prerequisite:
Experience and familiarity with ISO 9001:2000 and the ISO 13485:1996
standards are recommended.
What is a Webinar?
A TÜV webinar is an online training tool that can be attended in
the comfort of your own office. All you need is a computer, phone and
a high speed Internet connection. Simply join our live webcast to view
subject materials while attending a live conference call. Upon completion
of the webinar, all attendees will receive a copy of the presentation
materials.
About Our Subject Matter
Experts:
Our instructor is an expert with an impeccable track record and numerous
years of experience in both industry and product compliance.
Scheduled Dates
Cost: $149.00 per
person -
In North America
International Cost: $199.00
(International attendees
click here for more info)
Time: 1pm EST
Includes: Live webcast,
conference call and copy of presentation material
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