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.