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Clinical & scientific skills

ISO 20916:2019 — Clinical Performance Studies — Good study practice (CSS15)


Description
Agenda:
• IVDs regulatory framework
• Clinical Evidence – Performance Evaluation
• EU Regulatory Framework for clinical Performance studies
• Applicable Standards when conducting a Performance study
• Clinical Performance Study planning – Study design
• Need for informed consent
• Study submission / application
• Study conduct
• Study monitoring
• Safety reporting
• End of study requirements and document archiving
Content
  • Basic Training
  • ISO 20916
  • ISO 20916 - Presentation
  • Test
  • Assessment ISO 20916:2019
  • Training Content
Completion rules
  • You must complete the test "Assessment ISO 20916:2019"
  • Leads to a certificate with a duration: Forever
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