We develop and implement a methodologically sound procedure to collect, appraise, and analyse clinical data pertaining to your medical device.
We analyse test item materials at both sample and product level to assess process compatibility.
We validate your medical device cleaning instructions, as detailed in your IFU, which can be manual or automated.
We validate your medical device disinfection instructions, as detailed in your IFU, which can be manual or automated.
We validate your medical device sterilisation instructions, which can be moist heat, low temperature hydrogen peroxide or other process.
We perform accelerated aging testing and real time ageing studies to determine how a products behave under normal storage/use conditions over long periods of 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 offer comprehensive Extractables & Leachables (E&L) testing to identify and quantify substances, supporting your product’s biocompatibility and regulatory compliance.
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 cleaning instructions for medical devices, whether manual or automated, to ensure your process is fully validated.
