We develop and implement a methodologically sound procedure to collect, appraise, and analyse clinical data pertaining to your medical device.
We offer tests which evaluate cytotoxicity and biological risks within the chemical make-up of a medical device.
Our team will determine the presence or absence 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 complete Biological Safety Evaluation, following ISO 10993-1 standard to address possible biological hazards and risks associated with the clinical use of your medical device.
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 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.
