Evaluations carried out to determine the biological risks of medical devices are defined in ISO 10993 and a number of other product-specific standards, whereas the selection of applicable tests is device dependent.

We design all necessary studies. If you do not have in-house capacity, we arrange to have them carried out at laboratories that are best suited to your needs. We provide support with risk assessments and help you select the right studies. We collaborate with external contract partners or your in-house laboratories during the testing and reporting phases (monitoring). We check all-round compliance with regulatory and scientific requirements and standards, and help you prepare the final report.

Biological evaluation is usually part of a conformity assessment, but it can also be done as a stand-alone project.