Post-market clinical follow-up is an ongoing process to assess the safety and performance of a medical device throughout its entire life cycle. Both, the Medical Devices Regulation MDR and the directive on clinical evaluations MEDDEV 2.7/1 rev. 4 require a post-market clinical follow-up plan. Recently, both the PMCF plan and the evaluation report have been fix established in the clinical evaluation. Notified Bodies may also require manufacturers to carry out certain post-market clinical follow-up studies.
As long-time experienced organizer of clinical trials, we support you:
- Preparation of a post-market clinical follow-up plan (PMCF plan).
- Evaluation report on post-market clinical follow-up within the clinical evaluation.
- Study design, literature research and sample size calculation.
- Preparation of study documents including case report forms and application to the Ethics Committee.
- Statistical data analysis and report on the results of the post-market clinical follow-up study.
Documentation in English language, optionally in German language.