Our biocompatibility testing is a fundamental step in allowing a medical device to be recognised as safe for use. All medical devices which encounter human tissue should be subject to biocompatibility testing, critically cytotoxicity evaluation. Test labs offer tests which aid in addressing the biocompatibility of medical device materials. These tests are performed to ISO 10993-5 to determine cytotoxic potential.
To determine which test are relevant to your device, Test labs offer a biological evaluation plan (BEP) which will identify the tests needed for your medical device, as well as sourcing available information on your product. After constructing the BEP and performing the required tests and sourcing the biocompatibility information, Test labs offer a biological evaluation Report (BER) with the complete set of justifications and results on your product.
Explore our medical device testing services
Clinical Evaluation
We develop and implement procedures to collect, appraise, and analyse clinical data pertaining to your medical device.
Medical devices bioburden testing
Our team will determine the presence or absence of bioburden on your sterile or non- sterile medical devices.
Disinfection products for medical devices
We test the efficacy of a wide range of disinfectants for medical devices, including disinfection technologies and robots.
Explore our laboratory areas
Microbiology Laboratory
We are fully equipped to perform a wide variety of microbiology tests using bacteria, yeast, fungi, and bacterial spores.
Test chambers
We have built state of the art Test Chambers – all with a stainless steel interior and equipped with a wide range of sensors.
Chemistry Laboratory
Our chemistry lab is fully equipped to perform a wide variety of tests, that supports formulation and materials
development.