To assess the biological safety of medical devices, manufacturers need today to identify and evaluate potential risks resulting from the use of cleaning agents, packaging materials, possible contamination of raw materials, influences of sterilization, etc. on the biocompatibility of the product with the human body. Biocompatibility studies alone are no longer sufficient here in Europe to obtain or maintain the CE mark.
In addition to the risk-based approach, the consideration of possible toxicological effects of the product over its entire life cycle is also gaining in importance. Biological evaluation not only provides an additional aspect of safety for your medical device, you also benefit from valuable criteria for material procurement, incoming material control, and control during the production process or occupational safety.
We support you:
- Preparation or revision of your biological evaluation.
- Review of your biocompatibility studies.
- Organization of biocompatibility studies on request.
Documentation in English language, optionally in German language.