With the entry into force of the new regulation in May 2017, the area of medical devices is undergoing a massive change. The overall level of requirements has significantly increased and compliance with the general safety requirements remains a crucial point in the development and marketing of medical devices.
The evaluation of biocompatibility is one of the key steps to prove the biological safety of medical devices in a standard context that is more restrictive.
1- Evaluation of the biocompatibility of medical devices
2- Expertise in Toxicology
- Bibliographic searches
- Establishment of toxicological profiles
- Interpretation of biocompatibility testing results
- Analysis of non-compliant results and support for the identification of possible causes