Assessment of biomaterials and medical devices, verifying their serviceability or chemical and biological performance, as well as their safety (biocompatibility).
We assess biocompatibility under ISO 10993 through in vivo and in vitro biological tests, as well as chemical characterisation tests.
We carry out the following tests at our laboratory:
- Assessment of the antimicrobial activity on surfaces, liquids and dusts under reference standards and/or adapted to the product to be assessed.
- Adhesion and biofilm formation on surface tests.
- Microbiological tests. Agar-antibiogram diffusion.
- Tests with biocides (disinfectants) and antiseptics.
- Bioburden and sterility assessment.
- Cytotoxicity tests in different cell lines depending on the application of the product to be tested.
- Cell adhesion, proliferation and differentiation tests.
- Cell inflammation, apoptosis and necrosis tests.
- Molecular tests: extraction and quantification of DNA, RNA and proteins, expression of molecular markers via PCR, qRT-PCR and ELISA.
- In vitro skin and eye irritation and corrosion.
- In vitro sensitisation.
- Acute oral and dermal toxicity.
We adapt in vivo and in vitro toxicological testing methods to nanomaterials. We also carry out tests on the accumulation of nanoparticles in cells.
- Companies, universities and research centres working in the field of medical devices, ranging from research and development to manufacturing, that need to assess and validate their developments.
- Manufacturers of medical devices that need to validate the conformity of their medical devices prior to being placed on the market (CE marking).