We test the biological safety and biocompatibility of your medical device product. In addition to conducting biological studies according to the matrix of ISO 10993, the FDA Blue Book Memorandum, MHLW requirements, USP classification of plastics, including Class VI and other international guidelines, we offer our customers a variety of cell-based alternative methods or models under GLP conditions to investigate the hazard potential of medical devices.
Depending on the material, manufacturing methods of fabrication and the study objective, the most appropriate and customized testing strategies are selected.
What do we offer?
- Cytotoxicity (Various cell lines, validation according to ICH guidelines)
- Genetic toxicology (New methods for example Pig-a)
- Hemocompatibility (Static and dynamic studies)
- Sensitization
- Studies to determine local tolerability (Different routes of application)
- in vitro test systems for the substitution of animal models
- Acute systemic toxicity
- Pyrogenicity studies
- Subacute, subchronic and chronic toxicity*
- Implantation*
- Implantation combined with systemic toxicity*
* Combined with comprehensive histopathology
Bridging studies according to ISO 10993-2
Eurofins Medical Device Testing network also offers so-called bridging studies, which are used to determine the scientific background for the biological evaluation of a medical device. In this process, the biocompatibility of a product is compared and evaluated on the basis of material and literature data with the current study results.
Using this method, basic information for opportunity and risk assessment can be determined. In addition, the performance of these bridging studies takes into account the animal testing regulations according to ISO 10993-2.
Certificates and Expert Statements
Eurofins Medical Device Testing network provide its clients with certificates, expert statements and toxicological evaluation of test results as well as literature and material data. In line with the latest scientific developments, we provide you with the best testing strategy for your medical device.
If you want to discuss your project with our Business Development Manager Anja Kroon or request a quotation, feel free to contact us.
If you would like more information about our Medical Device testing capabilities visit our global Medical Device website using the following link: https://www.eurofins.com/medical-device/
