The concept of biocompatibility refers to the interaction between the tissues and the physiological systems of a patient treated with a medical device. The biocompatibility assessment is part of the overall device safety assessment.
Biocompatibility of medical devices has to be evaluated in the view of the latest ISO 10993 “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”. The biological test methods applicable for respective medical devices are classified in regard to their nature and duration of contact.
We offer comprehensive pre-clinical testing and consulting services of medical devices. We have our own laboratories that are among some of the most modern in all of Europe and we are proud to say we have a very broad field of tests we are able to conduct. We are not exaggerating by saying that to us nothing is impossible! We always advise our customers good and cost-effective solutions.
The biocompatibility tests applicable for respective medical device classified regarding to its nature, duration and time of body contact. Below you find a list of biocompatibility tests, that we conduct routinely.