- According to ISO 10993-1:2018, the Biological evaluation of medical devices has to be provided as part of the information needed to register a Medical Device.
- The evaluation aim is the protection of humans from potential biological risks arising from the use of medical devices.
- At Azierta, we provide comprehensive support covering the biocompatibility evaluation, evaluation of test results when necessary, the risk assessment report of medical devices and its regulatory management .
Our services include:
1. Biocompatibility evaluation
- Compilation of physical and chemical information on/about the medical device and its associated material characterization process.
- Material characterization.
- When considered necessary, biological testing methods for biological evaluation must be sensitive, precise and accurate.
- Biological tests should be carried out in accordance with good laboratory practices. The test methods should be reproducible as well as repeatable and robust.
- Based on the test results, our experts analyse the data and perform risk assessment.
3. Risk assessment reports for medical devices
- Expert toxicology evaluation report of a product is carried out to establish its biocompatibility.
“At Azierta we have a multidisciplinary team, our toxicological experts and regulatory team can support you in all the stages of the registration of a Medical Device”