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Clinical & scientific skills

CER - Clinical Evaluation (CSS12)


Description
1. Introduction to General Approach and Strategy
2. Objective of Clinical Evaluation
3. How and Where to start?
4. Content of Clinical Evaluation Documents
5. Practical Approach
6. CER for Legacy Devices
7. Concept of Equivalence
8. Intro to Performance based CER
9. Behaviour – General Working Practices
Content
  • 1.1 Introduction
  • Introduction to CER
  • Introduction to CER - Presentation
  • Introduction to CER - Q&A
  • Introduction to CER - Q&A - Presentation
  • 1.2 EMBASE
  • First steps in EMBASE
  • Embase for Medical Devices
  • Concept and principles of Embase
  • Dedicated detail training for Medidee (case studies)
  • 1.4 Introduction to SOTA Literature Review
  • Video - CER SOTA Tutorial (clone)
  • Introduction to SOTA Literature Review - Presentation
  • 1.4 Training on CEP/R template
  • 00- Introduction to new template.pdf
  • 01 - Overview of rank of evidence.pdf
  • 01– Overview of rank of evidence
  • 02 - Clinical evaluation strategy.pdf
  • 02 – Clinical evaluation strategy
  • 03 - Lit Search and Appraisal (Annex B).pdf
  • 03 – Lit Search and Appraisal (Annex B)
  • 04 - Lit Search and Appraisal (Annex A).pdf
  • 04 - Lit Search and Appraisal (Annex A)
  • 05 – Appraisal and analysis of data: evidence.pdf
  • 1.5 CEP/R and PMCF – BSI training
  • 1- Intro to CEP – BSI training
  • Intro to CEP – BSI training.aspx.mp4
  • 2- CER part I – BSI training
  • CER part I – BSI training.mp4
  • Case studies on S&P parameters
  • Case studies on S&P parameters - intro.pdf
  • Case studies on S&P parameters - Intro.mp4
  • Case 1 – ATF Hip implants.mp4
  • Case 2 - OMI eye drops.mp4
  • Case 3 – BBM Infusion pump.mp4
  • Test
  • Assessment CER Basic Training
  • Training Content
Completion rules
  • You must complete the test "Assessment CER Basic Training"
  • Leads to a certificate with a duration: Forever
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