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:
01. Table of content
03. Scope of the clinical evaluation
04. Clinical background, current knowledge, state of the art
05. Device under evaluation
06. Clinical data generated and held by the manufacturer
07. Clinical data from literature
08. Summary and appraisal of clinical data
09. Analysis of clinical data
11. Date of next clinical evaluation
12. Date & Signatures
13. Qualification of the responsible evaluators