Patient safety is paramount. But achieving it while also navigating complex, evolving regulations is no small task. From ensuring your device won’t cause adverse reactions, to proving biocompatibility across materials and components, the demands on your team are growing. You need reliable, regulatory-ready strategies. 

At Eurofins Medical Device Services (MDS), we understand the pressure to move quickly without compromising safety or compliance. Our global network of laboratories and consultants can support you with a Biocompatibility and Toxicology Evaluation using a depth of scientific expertise, regulatory insight, and tailored testing capabilities required to address biological risk with confidence and product efficacy. 

At Eurofins Medical Device Consulting, the design and delivery of tailored Biological Evaluation is based on ISO 10993 standards. Our approach assesses how materials interact with the human body to help mitigate potential adverse effects like allergic reaction, cytotoxic, or systemic effects, for patient safety. We deliver end-to-end Biological Evaluation Plans (BEPs) and biocompatibility consulting and testing services, designed to meet the demands of regulators while aligning with the specific materials and intended use of your device. Our team of experienced toxicologists is adept at identifying potential issues and providing strategies to address these prior to regulatory submission. We can scale consulting services to meet each device, whether it is a single project or regular ongoing support

Unexpected results? We’ve seen them before. Our teams work alongside you to troubleshoot anomalies and refine your BEP, ensuring your device stays on the right path toward approval.