We offer a comprehensive range of biocompatibility tests to evaluate potential biological risks arising from your medical device.
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 conduct accelerated and real time stability testing to determine shelf life of products as well how storage may affect device functionality and reprocessing over time.
Whether you’re refining a prototype, investigating a failure mode, or pushing the limits of what your device can do, we’re here to provide the technical testing support you need.
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 validate the full reprocessing lifecycle of your medical device, delivering the evidence you need to demonstrate regulatory compliance, ensure patient safety, and protect product longevity.
