Date :
Place : United States, Salt Lake City
Contact Person:John Robinson
Description:
The medical device industry is in the midst of major change, with the publication of the FDA's UDI Regulation, the first revision to the ISO Quality Management Systems standard in over a decade, and the upcoming changes to the EU's Medical Device Regulation expected to be passed later this year. All of these events have far reaching effects on Quality Management Systems so it is critical to understand what has changed with in ISO 13485: 2016 in order to create a comprehensive quality plan for your organization to ensure continued compliance and certification.Deadline for abstracts/proposals : 8th May 2018
Organized By :NetZealous LLC DBA GlobalCompliancePanel
Keynote Speakers : Lena Cordie Quality & Regulatory Consultant, Qualitas Professional Services, LLC Lena Cordie has over 20 years of quality and project management experience including: 10 years in project management at Target Financial Services 11 years as Director of Operations at Key Surgical, a medical device company focused on sterile processing, personal protection, and OR products. In this position she was responsible for overseeing all quality and regulatory functions, production, produ
Conference Highlights :Course "ISO 13485:2016 Implementation Workshop" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: The medical device industry is in the midst of major change, with the publication of the FDA's UDI Regulation, the first revision to the ISO Quality Management Systems standard in over a decade, and the upcoming changes to the EU's Medical Device Regulation expected to be passed later
Venue :Salt Lake City, UT, USA
Check the event website for more details.