MDR-Transfer & PMCF-Activities

Dear Business Partner,

Here you can let us know your inquiry without obligation.
Please select the applicable tasks according to your requirements.

   1. Development of a strategy for collecting clinical data
   2. Demand analysis regarding regulatory requirements (MDR)
   3. Writing/Updating of a Clinical Evaluation Report (CER) according to MDD
   4. Writing/Updating of a Clinical Evaluation Report (CER) according to MDR
   5. Development of a concept for a CER according to rule 1.1.d MDD
   6. Setting-up appropriate well structured PMCF-measures (PMCF-Plan, PMCF-Report)
   7. Conception and compilation of a Clinical Evaluation Plan (CEP)
   8. Post-Market Surveillance (PMS)
   9. Periodic Safety Update Report (PSUR)
10. Summary of Safety and Clinical Performance (SSCP)
11. Post-market surveillance reporting
12. Evaluation and justification of market potential

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