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The final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS). The new version has better alignment with FDA's QSR, but there are still major differences that create issues for effective QMS implementation. This workshop covers the differences from the 2003 version to the 2016 version and offers practical implementation advice to update your QMS. Participants will also learn the differences with QSR and understand how to resolve them. The workshop uses extensive examples and exercises to help clarify the concerns. Some regulatory systems will rely on ISO 13485:2016 through the Medical Device Single Audit Program (MDSAP). The US will participate in MDSAP, but doesn't expect to change its regulations.
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Timings09:00 AM - 06:00 PM (Jan 26 - Jan 27)
(General)
| Entry FeesCheck Official Website |
Estimated Turnoutupto 100 Delegates Based on previous editions | Event TypeConference |
EditionsJan 2017Frequency Annual | Official LinksWebsiteContactsReport Error Claim this event |
Event Happened Alongside Leadership and Team ... 26 - 27 Jan 2017 4 Followers Compliance Boot Camp 26 - 27 Jan 2017 | |
Different Located Editions Revere, USA16 - 17 Nov 2017 Morrisville, USA27 - 28 Apr 2017 | |
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4000 N Central Ave, Phoenix, AZ 85012
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