The smallest changes in design, raw material suppliers, or manufacturing processes can have the most unexpected impact, triggering biological reactions that can compromise patient safety, delay approvals, or even completely derail market launches. When patients’ lives are at stake, there is no room for uncertainty. Medical device developers face the most intense regulatory scrutiny and must ensure every component used is proven safe.

At the Eurofins Medical Device Services network of laboratories, we possess deep knowledge and expertise in the evaluation of new materials and suppliers, validation of long-term biostability, and stay abreast of evolving ISO 10993 expectations. We have more than 40 years of experience partnering with clients to deliver testing strategies that support global submissions and regulatory compliance.

Each of our laboratories is ISO/IEC 17025 accredited and compliant with FDA, EU, TGA, and OECD GLP guidelines, offering an end-to-end solution for biological risk assessment. Whether you're preparing for a new product submission or adjusting to a post-market change, our toxicologists, chemists, and biocompatibility experts help build your evidence base and navigate international standards

Our comprehensive biocompatibility testing services include:

• Assessment of the effects of sterilisation methods and material aging
• Biological Evaluation Plans (BEPs) and gap analysis of dossiers
• Biological testing, including the “big three” (cytotoxicity, sensitisation, irritation),  genotoxicity and hemocompatibility
• Chemical characterisation of materials, degradation products, and processing residues
• Evaluation of new device designs or manufacturing changes
• Extractables and leachables testing (E&L)
• Preparation of toxicology reports aligned with ISO 10993 standards
• Toxicological risk assessments (TRA), including Permitted Daily Exposure (PDE) analysis

In addition to traditional methods, we apply in silico approaches like QSAR and read-across, enabling you to identify and address potential hazards early in development. Our global team works closely with clients to interpret data and adjust strategies to keep projects moving forward efficiently and compliantly.

Backed by decades of experience in the medical device sector, Eurofins Medical Device Services customises testing programmes to meet the unique needs of Class I, II, and III devices, combination products, and innovative new materials. Whether your goal is first-to-market speed or deep safety insight, our team supports your device’s journey all the way through from concept to clinic.

Biocompatibility & Biological Evaluation Plan Services