Clinical Evaluation Procedure

The Clinical Evaluation Procedure governs the entire clinical evaluation process from scope definition through Clinical Evaluation Report (CER). The Clinical Evaluation Procedure also governs Post Market Clinical Follow-up (PMCF).

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Clinical Evaluation Procedure

The Clinical Evaluation Procedure governs the entire clinical evaluation process.

Clinical Evaluation Procedure Overview

The Clinical Evaluation Procedure provides detailed instruction on:

• defining the scope of a clinical evaluation;

• identification of pertinent data and literature reviews;

• appraisal of pertinent data; analysis of clinical data;

• generating a Clinical Evaluation Report (CER). The procedure includes an instructive CER report document with guidance for each section.

• conducting Post Market Clinical Follow-Up (PMCF)

The Clinical Evaluation Procedure also provides detailed instruction on Post Market Clinical Follow-up (PMCF).