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Pre-Clinical Studies

Audit & Governance plans, with its own resources, pre-clinical studies with models validated to demonstrate the safety, the mechanism of action and the performance of a medical device.

Audit-&-Governance-Pre-Clinical-Studies

For example:

  1. In-vitro / in-vivo tests to demonstrate the mechanism of action;
  2. In-vitro / in-vivo efficacy tests;
  3. Test of absorption, distribution, excretion and/or interaction with substances;
  4. Biocompatibility test according to ISO 10993 and, where not applicable, ad-hoc biocompatibility studies;
  5. Safety tests for food, medical devices and food supplements;
  6. Stability studies
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