For tissue-based devices, ensuring viral clearance is not just a regulatory hurdle, it’s a critical safeguard. But for many, especially those approaching submission for the first time, viral clearance studies can seem complex, time-consuming, and uncertain. The stakes are high, and you need to get it right. The Eurofins Medical Device Services network of laboratories is uniquely equipped to support you with consultancy on study design and virus selection. Our experts offer a powerful combination of in-depth regulatory knowledge, extensive viral safety experience, and state-of-the-art testing capabilities. Whether you’re validating your process or finalising submission, we can guide you through every step of your viral clearance programme.

Our dedicated viral clearance facility supports both GLP and non-GLP studies, following EN ISO 22442-3 and FDA guidance. We provide expert consultancy on study design, virus selection, and risk assessment. With a dedicated virus testing facility and extensive experience across a wide range of animal-derived matrices—including bone, tendon, cartilage, and liver—we design tailored studies that evaluate chemical and physical inactivation methods. Our virus panels are selected based on product-specific risk profiles and regulatory expectations, ensuring robust validation of viral removal or inactivation processes.

Backed by more than 15 years of viral safety expertise, our scientists ensure your viral clearance studies are efficient, effective, and regulatory ready. Whether you’re working with bovine, porcine, or other tissue-derived components, we offer practical, science-led strategies tailored to your product, process, and timeline.