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 prepare Biological Evaluation Reports (BERs) in accordance with ISO 10993-1, providing a clear, structured, and scientifically justified assessment of the biological safety of medical devices.
We offer the ISO 10993-5 Cytotoxicity in-vitro testing which evaluates the ability of a medical device to elicit a cytotoxic response in mammalian cells.
We offer in vitro ISO 10993-23 tests to determine irritation potential of a medical device, using a reconstructed human epidermis (RhE) skin model.
We provide chemical characterisation testing in accordance with ISO 10993-18, using extractables and leachables testing to identify and characterise chemical substances that may be released from medical devices throughout their intended life cycle.
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.
