1 / 8

Requirements of Clinical Evaluation Reports for Medical Device Manufacturers

MakroCare provides end to end Clinical evaluation reports for medical devices. Our expert team can provide CER reports within the time limit.

mattandrew
Download Presentation

Requirements of Clinical Evaluation Reports for Medical Device Manufacturers

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Requirements of Clinical Evaluation Report for Medical Device Manufacturers.

  2. Clinical evaluation Report Clinical Evaluation Report is an analysis of Pre market & post market clinical data of medical device which includes clinical performance & Clinical safety .

  3. Requirements of CER • Identification of Clinical Data • Appraisal of Clinical Data • Analysis of Clinical Data • Finalize the Report

  4. Identification of Clinical Data Classify the relevant Pre-market & Post-market clinical data.

  5. Appraisal of Clinical Data Appraise each identified data set for scientific validity, relevance to clinical evaluation.

  6. Analysis of Clinical Data The data analysis should include: • Benefit/Risk Profile • Residual Risks • Uncertainties or Unanswered Questions

  7. Finalize the Report After data analysis, the evaluation report should summarize the data analysis. This report should provide strong clinical evidence for conformity assessment so the device can be approved for sale in European markets.

More Related