Section 4: Summary of CEP
Section 4: Summary of CEP
MDR CER Writing
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1. Introduction & basic concepts
Training course introduction
What is Clinical Evaluation
Clinical Evaluation in context
Basic principles of planning a CER
Five common pitfalls when writing a CER
2. Section-by-section guide
Overall CER stucture
Free CER Template
Section 3: Scope of the Clinical Evaluation
Classifying medical devices
Hypothesis & hypothesis testing
Section 4: Summary of CEP
General Safety & Performance Requirements (GSPRs)
Appraisal & weighting
Section 5: Harmonised standards
Section 6: Clinical background / SOTA
Principles of a Literature Review
Section 7: Equivalence
Equivalence - Further details
Section 8: Clinical evidence review
Overall summary of evidence
Section 9: Analysis
GSPR 1 analysis - Further details
Section 10: Benefit-risk analysis
Section 11: Conclusion
Remaining sections
3. CER templates
Choosing a CER template
EnableCE CER Template
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MDR CER Writing
Buy now
Learn more
1. Introduction & basic concepts
Training course introduction
What is Clinical Evaluation
Clinical Evaluation in context
Basic principles of planning a CER
Five common pitfalls when writing a CER
2. Section-by-section guide
Overall CER stucture
Free CER Template
Section 3: Scope of the Clinical Evaluation
Classifying medical devices
Hypothesis & hypothesis testing
Section 4: Summary of CEP
General Safety & Performance Requirements (GSPRs)
Appraisal & weighting
Section 5: Harmonised standards
Section 6: Clinical background / SOTA
Principles of a Literature Review
Section 7: Equivalence
Equivalence - Further details
Section 8: Clinical evidence review
Overall summary of evidence
Section 9: Analysis
GSPR 1 analysis - Further details
Section 10: Benefit-risk analysis
Section 11: Conclusion
Remaining sections
3. CER templates
Choosing a CER template
EnableCE CER Template