Clinical Evaluation Procedure

SKU: SOP 7-038
$149.00
$149.00
Unavailable
per item

The Clinical Evaluation Procedure governs the entire clinical evaluation process from scope definition through Clinical Evaluation Report (CER).The MEDDEV 2.7/1 Rev 4 compliant Clinical Evaluation Procedure also governs Post Market Clinical Follow-up (PMCF).

  • MEDDEV 2.7/1 Rev 4 Compliant
  • MDR (EU) 2017/745 Compliant
  • ​ISO 13485:2016 Compliant
  • MS Word Format
  • ​Instant Download Digital Content

Clinical Evaluation Procedure

The Clinical Evaluation Procedure governs the entire clinical evaluation process. MEDDEV 2.7/1 Rev 4, MDR EU 2017/745, FDA QSR and ISO 13485:2016 compliant. ​

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 template 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). ​

Clinical Evaluation Procedure Compliance

​The clinical evaluation procedure is MEDDEV 2.7/1 Rev 4, MDR EU 2017/745, and ISO 13485:2016 compliant.​
For  more information about our Clinical Evaluation Procedure contact us at info@aplyon.com
Clinical Evaluation Procedure
Clinical Evaluation Procedure

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