Course Details

2019 Medical Device Fall Roadshow

Course Area

Medical Devices

Course Duration

1 Day

Continuing Education Units

0.6

Course Fee

USD $199.00

Early Bird Price*

USD $149.00

There are no upcoming classes scheduled.

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Course Details

Join BSI experts at our full-day EU Medical Device Roadshow where you can learn about some of the most significant changes to the European regulatory and compliance expectations for CE marking, enabling you to prepare for the new MDR/IVDR requirements effectively.

Agenda

8:30 - 8:50amWelcome and intro
8:50 - 9:50amEU initial lessons learned 
9:50 - 10:15amBrexit, Designation, and the EU Landscape 
10:15 - 10:30amCoffee break
10:30 - 11:30amClinical oversight 
11:30 - 12:00pm Class 1 re-usable surgical instruments 
12:00 - 1:00pmLunch
1:00 - 1:30pmApplying for MDR – New NB application process
1:30 - 2:15pm EU MDR pdates - PSUR, SSCP, Equivalent, Sufficient 
2:15 - 2:45pm Key standards updates 
2:45 - 3:00pm Coffee break
3:00 - 3:45pmQMS aspects of the MDR 
3:45 - 4:15pmEU MDR Updates - EUDAMED, Implant Card +
4:15 Questions/closing 

Live Online Classes

Certified, convenient, and interactive, with no travel costs.

Private Class

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Questions?

For questions regarding any of our courses, contact us or call 1.800.217.1390.

Questions?

For questions regarding any of our courses, contact us or call 800.217.1390 (USA) 800.862.6752 (Canada)

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