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.
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 validate your medical device cleaning instructions, as detailed in your IFU, which can be manual or automated.
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 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 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 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
