ADAX can assist with many aspects of the clinical evaluation process and Clinical Evaluation Report (CER) preparation as a part of medical device Technical Documentation:

  • scoping and identification of clinical data,
  • literature searching (a brief outline of the searching/retrieval process would be included in the CER and cross-referenced to the literature search protocol and reports),
  • collection of clinical experience,
  • clinical investigation,
  • appraisal of clinical data,
  • analysis of the clinical data,
  • concluding, reporting, and
  • update of clinical evaluation, including PMCF (MEDDEV 2.12/2).

Read more in our Publication: Medical Device – Clinical Investigation and Clinical Evaluation.