Much has changed

Within the last years a lot of requirements for MDs have changed and the clinical studies needed nowadays are much closer to drug approval requirements. However, there are still certain specifics which make the situation different.

And sometimes the borders are fluid!

Our clinical experience

We started our first medical device activities about 10 years ago, and we have been involved in the increasing influence of GCP standards since then. Our practical experience covers but is not limited to:

  • Nephrology and dialysis
  • Test kit development
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