2 Clinical Evaluation Report Sample
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Clinical Evaluation Report Sample

Clinical Evaluation Report Sample prepared for education and understanding. Below presented is the table of contents:

A clinical evaluation report shall be compiled to document the clinical evaluation and its output on a specified time schedule.

The clinical evaluation report should contain sufficient information to be read and understood by an independent party like regulatory authority or notified body.

Therefore, it should provide sufficient detail for understanding the search criteria adopted by the evaluators, data that are available, all assumptions made and all conclusions reached.

The contents of the clinical evaluation report are relevant to [Device Name] medical devices manufacture and marketed by [company name] which may vary according to the nature and history of the device under evaluation:

The Organization must follow following step while doing documentation of clinical evaluation report:

Clinical Evaluation Report Sample Templatet

01. Table of content

02. Summary

03. Scope of the clinical evaluation

  • General details

  • Device Description

  • Device Classification

  • Intended use

  • Contraindication

  • Indication of Use

    04. Clinical background, current knowledge, state of the art

    05. Device under evaluation

  • Type of evaluation

  • Demonstration of equivalency

  • Determination of equivalent devices

  • Analysis and evaluation of equivalent devices

  • Supporting data to claim equivalency

  • Biocompatibility testing (biological and clinical equivalence)

  • Bench testing (technical and clinical equivalence)

    06. Clinical data generated and held by the manufacturer

  • Post market surveillance study

  • Objective

  • Study design

  • Study outcome

  • Post market clinical follow up

  • Pre-clinical studies

    07. Clinical data from literature

    08. Summary and appraisal of clinical data

    09. Analysis of clinical data

  • Requirement on safety

  • Requirement on Acceptable Benefit/Risk Profile

  • Requirement on Performance

  • Requirement on acceptability of side-effects

    10. Conclusion

    11. Date of next clinical evaluation

    12. Date & Signatures

    13. Qualification of the responsible evaluators

    14. Reference

    15. Records

    Clinical Evaluation Procedure

    Additional Resources

  • CER Report.
  • CER-Frequently Asked Questions
  • Meddev 2.1.7/1 Rev 4 Clinical Evaluation.
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