CLINICAL STUDIES ON MEDICAL DEVICES

At Convex CRC we can conduct clinical investigations on medical devices with due compliance to the pertinent regulation as well as to ISO14155 thanks to our continuous training approach. We can recruit external medical specialists from any field in order to allow for a smooth and expert based clinical investigation. According to the national Law on Medical Devices clinical investigation with such shall be carried out only in order to establish the following:

  • Confirm that under normal conditions of use the device performs one or more of its functions, determined by the manufacturer
  • Identify adverse side effects under normal conditions of use of the device
  • Assess to what extend the identified adverse side effects are within the acceptable risk in comparison to the benefit of the intended purpose of use of the device
  • Change the intended purpose of a CE marked medical device