We offer a comprehensive range of biocompatibility tests to evaluate potential biological risks arising from your medical device.
We support the safety and regulatory compliance of your medical device through robust Biological Evaluation Plans aligned with ISO 10993‑1, addressing potential biological hazards and risks throughout clinical use.
We produce a report which is a collective summary of all data used to assess the biocompatibility of your medical device.
We offer ISO 10993-5 cytotoxicity in vitro tests which evaluate biological risks within the chemical make-up of a medical device.
We offer ISO 10993-23 tests to determine irritation potential of their devices without the need for animal testing.
We offer comprehensive Extractables & Leachables (E&L) testing to identify and quantify substances, supporting your product’s biocompatibility and regulatory compliance.
We assess hydrogen peroxide residues remaining on medical devices following H2O2 sterilisation processes to assess biocompatibility and patient safety.
We develop a plan to gather the clinical data required to achieve your commercial goals.
