Eurofins Medical Device Testing
From implants and instruments, to single-use and combination products, as well as active electronic devices, Eurofins Medical Device Testing provides the optimal testing strategy for all types of class I, II and III medical devices and are dedicated to helping you verify and validate your product designs; confirm safety and efficacy; and ensure user needs are met.
With extensive knowledge of the commercialization process, international regulatory requirements, and scientific trends, our scientists and engineers have been assisting companies, large and small, with developmental testing and regulatory submissions for more than 25 years.
Our 16 state-of-the-art facilities throughout North America, Europe and Asia Pacific offer extensive capacity and the highest level of instrument technology, enabling us to provide the full scope of testing services required by the Medical Device Industry, with rapid turnaround times and unsurpassed customer service.
With an unwavering commitment to global regulatory standards, Eurofins Medical Device Testing can help develop and execute your test plans, and navigate the regulatory pathway to market anywhere in the world. We maintain quality systems compliant with cGMP, GLP and ISO 17025, and conduct testing in accordance with ISO, ASTM, ANSI, AAMI standards, as well as custom test methodologies to meet our customers’ unique challenges.
- Chemical/Physical Analysis
- Microbiology & Sterility
- Packaging & Seal Integrity
- Biocompatibility Testing
- Combination Products
- Medical Electrical Equipment
- Notified Body Services