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Welcome! 0 hr 1 min
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Session Recording 0 hr 47 min
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Presentation Slides 0 hr 5 min
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Conclusion 0 hr 1 min
From Self-Declaration to Certification: Proving Performance Under IVDR
Learn best practices around proving performance under the new IVDR requirements.
This session will cover:
- Evaluation Plans
- Ethics Committee (IRB)
- Member State requirements
- Managing a clinical study (protocol, data forms, deviations)
- Preparing performance studies for submission
- PMPF considerations and PMS
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