Services available for Single use instruments

We create regulatory‑ready clinical evidence to demonstrate safety, performance, and clinical benefit under EU MDR and UKCA for you medical device.

We offer a comprehensive range of biocompatibility tests to evaluate potential biological risks arising from your medical device.

We offer Bioburden testing which determines the presence of bioburden on your sterile or non-sterile medical devices.

We analyse test item materials at both sample and product level to assess process compatibility.

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 in vitro ISO 10993-23 tests to determine irritation potential of a medical device, using a reconstructed human epidermis (RhE) skin model.

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.

We develop a plan to gather the clinical data required to achieve your commercial goals.