With medical devices growing in complexity and sophistication, developers and manufacturers need to be 100% certain their cleaning, disinfection, and sterilization procedures are both effective and fully validated. Knowing how to design these processes, which test methods to apply, and how to interpret results can be a challenge without special expertise.

The Eurofins Medical Device Services network of laboratories is your partner in navigating this complexity. With years of experience in reprocessing validations, we provide a comprehensive portfolio of microbiological, biochemical, and toxicological testing tailored to your devices.

Our work is guided by globally recognized standards, including AAMI TIR12, ANSI/AAMI ST98, FDA guidelines, ISO 17664-1, and ISO 17664-2, ensuring your reprocessing procedures meet both clinical and regulatory demands. We collaborate closely with device manufacturers of all sizes to:

• Evaluate the effectiveness of cleaning, disinfection, and Instructions for Use (IFU), for both manual and automated systems
• Generate validation reports for inclusion in regulatory dossiers
• Identify worst-case inoculation sites through expert consultation
• Optimize Instructions for Use (IFUs) to reflect validated protocols
• Select clinically relevant test soils and organisms for accurate simulation of real-world use

Whether your product is undergoing design, reuse evaluation, or regulatory submission, Eurofins Medical Device Services can deliver the insight, infrastructure, and capacity you need. Even under the pressure of tight timelines, our network of laboratories is designed for scalability and redundancy, ensuring dependable turnaround and continuity.

Validate your cleaning and reprocessing processes with confidence.