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.
Biocompatibility assessment process – trust our expertise in biological evaluation
We assist with the categorisation of your medical devices and analyse physical as well as chemical information in detail, in order to evaluate further steps in a risk analysis following the current ISO 10993-1:2018. If there is no precise chemical information available, we will discuss the execution of chemical characterisations according to the current ISO 10993-18:2020 with you.
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 collaborate either with external contract partners or your laboratory during the design- test- and reporting phases.
Based on the results, SCC performs a risk assessment using toxicological literature and database data. In many cases, sufficient data is already available and no or just a limited number of biological tests are required.
In case further studies are required for the biological evaluation, we prepare the test plan together with the testing laboratory. We check all-round compliance with regulatory and scientific requirements and standards including the ISO 10993 (monitoring).
After completion of the studies, we prepare a final report as part of the conformity assessment procedure. In addition to the summary, discussion and evaluation of all results, the report also contains a detailed justification for waiving unnecessary tests.
Summary:
- Evaluation of physical and chemical information (considering ISO 10993-18)
- Risk assessment in line with ISO 10933-1
- If required, preparation of study design together with the lab
- If required, study monitoring of biological tests
- Preparation of final report
Your benefits:
- With good knowledge of the impact of various substances, we carefully select the tests to be performed. This strategy not only helps to save time and costs, but also avoid unnecessary animal testing.
- As early as the development phase, we can draw important conclusions based on cost-effective pre-evaluations, which help you prevent aberrations.
- We have been working with numerous national and international testing laboratories and know which ones can best meet your needs.
- 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.
How can we help?
Contact our experts if you have questions with respect to biological evaluation of your medical devices, preparing to place them on the market or considering their safety profile.