Biocompatibility testing is a critical part of the regulatory approval process for medical devices as even the best designed products can produce unintended complications if the materials used cause a biological reaction in the patient. Well characterised materials widely used in the industry can produce unexpected reactions if processed in a way that leads to contamination, degradation, or leaching of toxic compounds into a patient.
The Eurofins Medical Device Testing network of laboratories is ISO 17025 accredited and has expertise in a wide range of products and manufacturing processes to help assess the biological risks of a new device design or process change, and develop an appropriate testing program for assessing the safety of your products.
From chemical characterisation of degradation products and extractables and leachables testing, to toxicological risk assessments and biological evaluations, our veterinarians, chemists, and toxicologists can facilitate the appropriate testing to best support your international regulatory submissions, ensuring compliance to ISO standards (ISO 10993).
Choose Eurofins Medical Device Testing to help you:
- Evaluate the biocompatibility of your new device
- Assess the impact of a design change or new manufacturing process on your device’s safety
- Evaluate new raw material suppliers
- Consider effects of sterilisation techniques or long-term material stability
- Generate toxicology reports
- Establish biological evaluation plans
- Conduct gap analyses of existing biocompatibility dossier
What do we offer?
- Biological Evaluation Plan
- Chemical Characterisation
- In-vitro/In-vivo testing
- Cytotoxicity testing (Various cell lines, validation according to ICH guidelines)
- Toxicology services (Toxicological Risk Assessments, Genetic Toxicology, Alternative Toxicology)
- Hemocompatibility (Static and dynamic studies)
- Sensitisation
- Irritation
- 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*
- Implant testing *
- Implantation combined with systemic toxicity*
* Combined with comprehensive histopathology
Full overview of our biocompatibility testing services, visit our global website: https://www.eurofins.com/medical-device/testing/biocompatibility/
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.
Why choose Eurofins Medical Device Services?
- Single point of contact. Benefit from streamlined communication through a single local point of contact while leveraging the advantages of our extensive global network.
- Complete service portfolio. Leveraging our network of regulatory experts, laboratories, and sterile packaging sites in Europe, North America, & Asia Pacific, we can offer a comprehensive service portfolio to our customers.
- Extensive expertise. Companies of all sizes benefit from our 40+ years of expertise and capabilities to ready their products for market launch and post-marketing activities through three independent services: consulting, testing, and sterile packaging.
If you would like to discuss your project and needs 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, please also visit our global Medical Device website using the following link: https://www.eurofins.com/medical-device/
