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Course Details

Clinical Masterclass series: Clinical Evaluation Medical Software and AI Devices

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

Overview 

Join Richard Holborow, Global Head of Clinical Compliance, as he looks at the BSI interpretation of MDCG 2020-1 and how clinical evaluation should be applied to this group of devices

Key Lessons and Takeaway

Topics covered in this presentation: 

  • MDR Requirements 
  • When a Clinical Evaluation of Software is required 
  • MDCG 2020-1
  • The clinical evaluation Process for MDSW 
  • Considerations for Clinical Investigations 
  • Equivalence & Article 61 (10) 
  • Questions 

Presenter Information

Richard Holborow, Head of Clinical Compliance 

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Questions?

For questions regarding any of our courses, contact us or call 1.800.862.6752.

Questions?

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

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