Biocompatibility tests allow to evaluate the presence or absence of a potential biological risk connected with the use of the device on humans. The tests to be performed are established by the guiding standard UNI EN ISO 10993-1 and / or USP based on the type of devices, their invasiveness and the duration / type of contact with human tissues. The biocompatibility tests carried out are conducted in strict compliance with and in accordance with the specific standards identified for each type of test and according to the internationally recognized methodologies. Coronati Consulting is able to offer qualified support for the drafting of a detailed study program for each type of medical device.
For some of these tests, Coronati Consulting Lab collaborate with qualified, accredited and certified external laboratories.