Eurofins Medical Device Services North America, part of a network of over 20 medical device testing labs and a medical device solutions partner, launched a GMP PFAS testing and screening solution.

According to the company, it’s the first such offering developed and sold for the medical device industry. The solution provides insights to medical device manufacturers as they navigate the evolving PFAS global regulations, in order to contribute to medical device and patient safety.

Per- and polyfluoroalkyl substances (PFAS) are a group of over twenty thousand chemical compounds that are highly resistant to degradation and have been found to pose potential threats to human health and the environment. Implementing PFAS testing in the early development stages allows medical device manufacturers to prepare for potential regulatory updates and avoid future shutdowns, recalls, and liability issues while supporting sustainability goals.

The company’s GMP PFAS testing and screening solution includes combustion ion chromatography (CIC) for total organic fluorine screening in solids, liquids, and gases, to provide an initial assessment of PFAS levels. It also features process mapping and supply chain audits to identify contamination pathways.

Solvent extraction and direct combustion are available for flexible sample formats, as well as extractables & leachables (E&L) testing, toxicological risk assessments, and aging studies. Stability and forced degradation studies can also identify PFAS breakdown products.

The company operates under ISO 17025 accreditation standards, and applies GMP best practices, ensuring sensitivity, specificity, and reproducibility even at trace levels.

In July, Kimberly Ehman, Ph.D., joined Eurofins Medical Device Services’ North America Medical Device Program as head of Regulatory Toxicology to lead biocompatibility consulting and toxicological risk assessment (TRA) services.