Biocompatibility: demonstrated biological safety of your materials.
We conduct your device's biological evaluation under the ISO 10993 series, prioritising a risk-based approach: material characterisation, toxicological assessment and a reasoned selection of the tests actually needed - avoiding unnecessary testing.
We plan biocompatibility through risk assessment, rather than a blind checklist of tests.
Biological Evaluation Plan (BEP) under ISO 10993-1.
Chemical characterisation of materials and toxicological risk assessment.
Definition of the testing matrix (cytotoxicity, sensitisation, irritation, etc.).
Coordination of testing with qualified laboratories.
Biological Evaluation Report (BER) integrated with risk management.
What you receive
Reference standards
- ISO 10993-1 and other parts of the series (biological evaluation of devices).
- ISO 14971 - risk management (integration of biological evaluation).
- ANVISA, FDA and MDR biocompatibility requirements.
Frequently asked questions
Does your device come into contact with the body?
We demonstrate biological safety under ISO 10993, without unnecessary testing.
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