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Course Details

Performance Evaluation under the In Vitro Diagnostic Regulation - Part 1 webinar

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

Join this webinar to hear Dr Liz Harrison, IVD Technical Team Manager at BSI, and Dr Erica Conway, BSI’s Global Head of IVD Medical Devices, talk about the Performance Evaluation requirements under the In Vitro Diagnostic Regulation (IVDR). 

Topics covered will include:
  • Requirements and expectations around a Performance Evaluation Plan and Performance Evaluation Report 
  • Scientific Validity and how this fits into the Performance Evaluation and clinical evidence 
  • BSI lessons learned to date with initial IVDR submissions 

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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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