About

About Hohenstein Medical Hohenstein Medical is a global, best-in-class GLP-certified and ISO/IEC 17025-accredited laboratory, conducting biocompatibility testing for medical devices, including analytical chemical characterization assays, biological in-vitro tests and microbiological evaluations. Hohenstein is one of the few laboratories accredited in chemical, physical and biological testing—offering an integrated approach to medical product evaluation. This full-scope capability provides manufacturers peace of mind with consistent, efficient studies aligned with the U.S. FDA, EU MDR, ISO-10993 and other regulatory requirements. Hohenstein Medical works with medical device and raw materials, offering comprehensive testing services, including single-use and reusable, finished devices and components, patient-contact and protective equipment — all tailored to the intended use, classification and regulatory pathway. The team collaborates with clients to customize study designs when standard methods are not sufficient. Hohenstein Medical is a division of Hohenstein Laboratories, a leading provider of independent testing, research and certification with more than 75 years of scientific experience. Hohenstein Medical is a global, best-in-class GLP-certified and ISO/IEC 17025-accredited laboratory, conducting biocompatibility testing for medical devices, including analytical chemical characterization assays, biological in-vitro tests and microbiological evaluations. Hohenstein is one of the few laboratories accredited in chemical, physical and biological testing—offering an integrated approach to medical product evaluation. This full-scope capability provides manufacturers peace of mind with consistent, efficient studies aligned with the U.S. FDA, EU MDR, ISO-10993 and other regulatory requirements. Hohenstein Medical works with medical device and raw materials, offering comprehensive testing services, including single-use and reusable, finished devices and components, patient-contact and protective equipment — all tailored to the intended use, classification and regulatory pathway. The team collaborates with clients to customize study designs when standard methods are not sufficient. Hohenstein Medical is a division of Hohenstein Laboratories, a leading provider of independent testing, research and certification with more than 75 years of scientific experience.