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Regulatory Affairs

Clinical Evaluation

The aim of a Clinical Evaluation according to MEDDEV 2.7/1 rev.4 is to demonstrate the in vivo performance and safety of a medical device. This evaluation is based on a systematic literature search and an analysis of all relevant data. Basically, the following questions have to be answered: 

 

  • What benefits will a medical device have in clinical use?
  • What risks and side effects are to be expected?
  • Are the risks acceptable compared to the benefit?

 

Our experience in the field of implant testing, our direct connection to university research, and our interdisciplinary team are an ideal combination for preparation of a clinical evaluation that is both scientifically and technically sound.

 

Meet our experts at experts@spineserv.de or by phone at +49 731 3885 1946.