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 characterized 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.
Eurofins Medical Device Testing has expertise in a wide range of products and manufacturing processes to help assess the risks of a new device design or process change, and develop an appropriate testing program for assessing the safety of your products.
From chemical characterization 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.
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 sterilization techniques or long-term material stability
✔ Generate toxicology reports
✔ Review the biocompatibility evaluations for your international regulatory submissions
✔ Establish biological safety plans and conduct gap analysis of existing biocompatibility dossiers
|Biocompatibility Testing Services|
|Chemical Characterization Testing|
|Extractables & Leachables||Degradation Products||Residual Ethylene Oxide|
|Toxicological Risk Assessments||Genetic Toxicology||Alternative Toxicology|
|In Vitro Biocompatibility Testing|
|Developmental and Reproductive Toxicity|
|In Vivo Biocompatibility Testing*|
|Systemic Toxicity||Implantation||Developmental and Reproductive Toxicity|
*Testing is performed by our partner lab