Medical Device Testing Services

We offer tests which evaluate cytotoxicity and biological risks within the chemical make-up of a medical device.

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 10993-23 tests to determine irritation potential of their devices without the need for animal testing.

We test your medical device reprocessing procedures, as detailed in your IFU, validating the cleaning, disinfection and sterilisation cycles.

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 develop and implement a methodologically sound procedure to collect, appraise, and analyse clinical data pertaining to your medical device.

Our team will determine the presence or absence of bioburden on your sterile or non- sterile medical devices.

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.

We will determine the efficacy of your medical device disinfectant wipe, as well as perform Material Compatibility tests.

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

We perform assessments of medical device packaging, labels and markings to determine the robustness during the life cycle of the device.

We will determine the efficacy of your medical device disinfectant spray, as well as perform Material Compatibility tests.

We assess the efficacy of UV-C light technology units and systems against the latest industry standards.

We test a wide range of technologies including disinfection robots, fogging machines, electrostatic hand sprayers.

We offer tests which evaluate the efficacy of your air purification systems against our in-house methods, based on international standards.

We use in-house methods and technologies to repeatedly operate devices and prototypes without human intervention to provide crucial data in accelerated time.

We test your device, mitigating the cost of repeated compliance testing by evaluating potential non- compliances.

We support you in the testing and certification of your medical devices and systems according to national and international standards and regulations, e.g. by application of IEC 60601 series