We offer our customers a product and services portfolio which allows supporting your product development and product authorization in a highly efficient process. Therefore we attach great value to comprehensive person-to-person consultation, a high degree of customer orientation, high quality and flexibility.
Biological tests of medical devices according to the DIN EN ISO 10993 are one of the main preconditions for the medical device authorization process.
As an accredited laboratory we can offer you in-vitro testings of all medical devices.
-
DIN EN ISO 10993-3, Test for gentoxicity - details
-
DIN EN ISO 10993-4, Test for interaction with blood (hemocompatibility) - details
-
DIN EN ISO 10993-5, Test for in vitro-cytotoxicity- details
-
DIN EN ISO 10993-10, Test for in-vitro irritation - details
-
OECD 442D, Test for in vitro skin sensitisation KeratinoSensTM
-
USP 40-NF35:2017, Test for endotoxin-mediated pyrogenetiy - details
Questions about our tests and services?
Please call us +49 7244 60 82 65 or
send us an email: