Clinical/Performance Evaluation Reports
It’s a fact, ALL Clinical Evaluation Reports (CERs) will need to be updated according to the State of the Art requirements under MDR. MD-CLINICALS’s medical writing team in collaboration with our regulatory experts are experienced in getting compliant clinical evaluation process in place.
- Determine clinical evaluation plan (including Methodology, Search protocols, appraisal plans etc), based on well defined claims
- Perform literature search and appraisal
- Write CERs/PERs and ensure relationship with Post Market Surveillance Plan and Risk Assessment process
- Trouble shooting – got on the wrong path with your NB ? – we can intervene and correct in shortest deadlines possible