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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
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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 Turnout1000-2000 Delegates Based on previous editions | Event TypeConference |
EditionsJan 2017Frequency Annual | Official LinksWebsiteContacts Report Error Claim this event |
| Event Happened Alongside Leadership and Team ... 26 - 27 Jan 2017 6 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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33.492473-112.075469 Venue Map & Directions | |
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What type of products / services will be showcased in the event?
Quality Management etc. are some of the products / services to be showcased in Implementing ISO.
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Linda Martinez
Linda Martinez
Phoenix, United States
Sergio Rivas
Instructor
Phoenix, United States
Tsz Wong
none
Phoenix, United States
Karl Adkins
Retired
Phoenix, United States
Sayya Wright
Operator
Phoenix, United States
Cheryl Hebert PhD
Professor Communication Studie
Phoenix, United States
Jeffrey Chien
Engineer
Phoenix, United States
Melissa Maness
Education Manager
Phoenix, United StatesView More
33.492473-112.075469
Venue Map & Directions
4000 N Central Ave, Phoenix, AZ 85012
USA
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