Learning Marketplace

2019 Medical Device Fall Roadshow

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 

Upcoming Course Dates

The venues for scheduled courses are tentative until receipt of course confirmation from BSI.

Start/End Date and Time Location Fee Enroll
  • Oct 23, 2019 8:30 AM - 4:30 PM
Boston, MA
The Westin Waltham Boston
70 3rd Avenue
Waltham, MA 02451
United States
781-290-5600
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USD $199.00Enroll