Eurofins Medical Device Services US

Medical Equipment ManufacturingPennsylvania, United States11-50 Employees

From implants and instruments, to single-use and combination products, as well as active electronic devices, Eurofins Medical Device Services network of laboratories 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, medical device preclinical testing, 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 40 years.
Our >20 state-of-the-art medical device services 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, including Analytical Chemistry, Microbiology, Biocompatibility, Electrical & Mechanical, Packaging and Stability Testing & Storage.
With an unwavering commitment to global regulatory standards, Eurofins Medical Device Services network of laboratories can help develop and execute all types of medical device testing 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.

Eurofins Medical Device Services is a brand used by several distinct legal entities, across a global network of more than 20 laboratories across North America, Europe and Asia Pacific.

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