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 test your device, mitigating the cost of repeated compliance testing by evaluating potential non- compliances.
We test your medical device reprocessing procedures, as detailed in your IFU, validating the cleaning, disinfection and sterilisation cycles.
We use in-house methods and technologies to repeatedly operate devices and prototypes without human intervention to provide crucial data in accelerated time.
We perform assessments of medical device packaging, labels and markings to determine the robustness during the life cycle of the device.
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 will determine the efficacy of your medical device disinfectant wipe, as well as perform Material Compatibility tests.
We will determine the efficacy of your medical device disinfectant spray, as well as perform Material Compatibility tests.
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.
