Clinical Evaluation as per MEDDEV 2.7.1 Rev 4

FDA 510k & CE Marking
December 16, 2015
Clinical Evaluation Report
August 14, 2018

Clinical Evaluation as per MEDDEV 2.7.1 Rev 4

Latest requirement to fulfill MDD compliance for Medical Device Manufactures!!!

 

Clinical Evaluation Reports (CERs)
Preparing a clinical evaluation report (CER) is time consuming and always need the support of skilled consultants. A post-market surveillance plan for each medical device or device family that specifies the frequency of performing a review and update of your clinical evaluation report (CER).

What are included in Clinical Evaluation Report?

  • Published and Unpublished Literature Search and consolidate a Report .
  • Selection of Databases from the above
  • Selection of Key Words based on the technical File and Design Parameters .
  • Inclusion & Exclusion Criteria
  • Addressing Risks .
  • Review of Post-Market Surveillance
  • Appraisal of Clinical Literatures .
  • Review and Update of Clinical Evaluation Reports (CERs)

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To know more about Medical Device Clinical Evaluation Report annual updatesClick Here >>>

1 Comment

  1. Arun says:

    Medical Device Clinical Evaluation as per MDR 2017/745 Article 61

    clinical evaluation shall follow a defined and methodologically sound procedure
    A manufacturer of a device demonstrated to be equivalent to an already marketed device not manufactured by him, may also rely on paragraph

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