Medical devices – Biocompatibility
The biological evaluation (or biocompatibility test) of your medical device is a mandatory part of the conformity assessment.
Biological Evaluation of medical devices by ISO 10993
Evaluations carried out to determine the biological risks of medical devices are defined in ISO 10993 and product-specific standards, whereas the selection of applicable tests is device-dependent.
- We have been working with numerous national and international testing laboratories and know which ones can best meet your needs.
- With good knowledge of the impact of various substances, we carefully select the tests to be performed. This strategy not only helps to save costs, but also avoid unnecessary animal testing.
- As early as the development phase, we can draw important conclusions based on cost-effective pre-examinations, which help you prevent aberrations.
- In many cases, risk analysis can be supported by computer simulations. Rely on the expertise of our regulatory science team, helping you to draw the precise conclusions you need for your risk assessment by applying commonly available data combined with suitable models.
Biocompatibility assessment process – trust our expertise in biological evaluation
We design all necessary studies in line with ISO 10993. 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.
- Risk analysis
- Preparation of study design
- Study monitoring
- Preparation of final report
Don’t hesitate to contact us directly if you would like to learn more about our services for the biological evaluation of your medical devices.