Learning Marketplace

2019 Medical Device Fall Roadshow

The class already has the maximum number of students. For more information or options please call Training Solutions at 800-217-1390.

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 14, 2019 8:30 AM - 4:30 PM
Newport Beach, CA
Hyatt Regency John Wayne Airport, Newport Beach
4545 MacArthur Boulevard
Newport Beach, CA 92660
United States
949 975-1234
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USD $199.00Enroll
  • Oct 16, 2019 8:30 AM - 4:30 PM
San José, CA
Crowne Plaza San Jose-Silicon Valley
777 Bellew Drive
Milpitas, CA 95035
United States
408-321-9500
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USD $199.00Enroll
  • Oct 18, 2019 8:30 AM - 4:30 PM
Minneapolis, MN
Minneapolis Marriott Northwest
7025 Northland Drive North
Brooklyn Park, MN 55428
United States
763-536-8300
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USD $199.00Enroll
  • Oct 21, 2019 8:30 AM - 4:30 PM
Bridgewater, NJ
Bridgewater Marriott
700 Commons Way
Bridgewater, NJ 08807
United States
908-927-9300
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USD $199.00Enroll
  • 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 $149.00*Enroll