Course Details

Understanding Regulatory Requirements & Standards Deadlines

Student taking online training

Course Area

Medical Devices

Availability

Available for 90 days after enrollment

Approximate Course Run Time

1 hour

Continuing Education Units

0.1

Course Fee

No charge

E-learning content is available on demand

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Course Details

Hear from our leading experts on the subject matter

Learn about key transition timelines including deadlines for: having an IVDR compliant QMS, formal applications lodged and formal written agreements.

  • Status Quo of the IVDR and the Notified Bodies
  • Regulatory Updates for IVDR
  • Implementation of 2024/1860 (IVDR Extensions)
  • EUDAMED Update

Speaker

Alex Laan, Dipl-Ing, Head of IVD Medical Devices Notified Body BSI

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Questions?

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

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