Services available for Class IR Instruments

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

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.