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.

What can we do for you?

Please contact us without obligation and we will be delighted to advise you on your individual requirements.