Navigating the medical device regulatory landscape is complex, especially when safety, compliance, and speed to market are on the line. Knowing what will be tested, how long it will take, and just what the regulatory requirements are for each type of device demands special expertise. Whether you’re developing a Class I, Class II, or Class III device, testing strategies must be robust, precise, and aligned with global standards.

The Eurofins Medical Device Services network of laboratories can verify and validate your product designs, confirm biocompatibility and efficacy, and ensure regulatory readiness. We support developers at every stage, from concept design to commercialisation, with testing solutions that can be customised to fit each device's class, complexity, and intended use.

For more than 40 years, our scientists and engineers have worked alongside product and device developers of all sizes throughout the world, providing regulatory guidance and executing test plans designed to withstand scrutiny from global regulators.

Our medical device testing facilities are spread over more than 20 sites across North America, Europe, and Asia Pacific, and are equipped with leading instrumentation, rapid capacity, and deep scientific expertise in core categories including:

• Accelerated and real-time aging
• Biological safety and biocompatibility (ISO 10993 series)
• Chemical and physical characterisation
• Combination product testing
• Mechanical and functionality testing
• Microbiology and sterility (bioburden, endotoxins, validation)
• Packaging and seal integrity (ISO 11607)
• Toxicological risk assessment and cytotoxicity testing
• Viral clearance

We maintain quality systems aligned with cGMP, GLP, and ISO 17025, and perform testing in accordance with ISO, ASTM, ANSI, and AAMI standards. Our teams also develop custom test methods as needed.

If you are new to medical device development, Eurofins Medical Device Services can help you map testing timelines, build a biological evaluation plan, and guide your team through regulatory requirements. For larger developers, we support critical path milestones, deliver results on deadline, and accommodate compressed schedules.

Our services are built to address:

• Delays due to underestimating sample quantities or lead times
• Lack of in-house expertise in regulatory or test design
• Unfamiliarity with required standards and global requirements
• Unexpected test outcomes that require quick resolution
• Validation support for complex combination or active devices

From biological safety to packaging durability, the Eurofins Medical Device Services network of laboratories offers integrated solutions to help your medical device make it to market safely, quickly, and with complete regulatory confidence.

Plan your testing strategy.