Clinical evaluation

With their long-standing experience and extensive medical knowledge, experts from KMJ pharma® Sp. z o.o. offer our clients the preparation of clinical evaluation of a medical device or an active medical device in order to:

  • confirm compliance with basic requirements regarding properties and effects of an evaluated device,
  • evaluate any undesirable effects and acceptability of the risk/benefit ratio under normal conditions of use of the evaluated device.

Clinical evaluation is carried out on the basis of clinical data or data coming from in vitro or in vivo laboratory tests performed in research units.

The clinical evaluation prepared by us includes all harmonized standards regarding an evaluated device and is carried out according to a definite and methodologically reliable procedure based on:

  1. The critical evaluation of the currently available academic literature regarding safety, effects and properties of a project and the expected application of the evaluated device, if:
    • The equivalence of the evaluated device to a medical device or an active medical device for implantation the data refers to has been demonstrated, and
    • The data shows compliance with basic requirements referring to this device;
  2. The critical evaluation of results of all clinical studies;
  3. The total critical evaluation of the data referred to in paragraphs 1 and 2.

The clinical evaluation of an active medical device for implantation, a medical device for implantation and a third class medical device is carried out on the basis of clinical data that comes from a clinical study, unless this evaluation based on existing clinical data is adequately justified.