BOENNIGHEIM, Germany & LIGONIER, Indiana (Nov. 4, 2025) — Hohenstein Medical – a division of Hohenstein Laboratories and a leading provider of testing, research and certification services for medical devices – has hired Katie Brinkman as its biocompatibility program manager to lead and support the company’s growing biocompatibility service offerings for the medical device industry. In this role, Brinkman will lead the development and strategic positioning of Hohenstein Medical’s device biocompatibility program, with a focus on chemical characterization, ISO 18562 gas pathway testing and ethical, non-animal assays. Her work will also include biocompatibility consulting, including biological evaluation plans and reports.
“We’re thrilled to welcome Katie to the Hohenstein Medical team as we continue to serve our customers using the highest international standards for regulatory studies and lab competence,” said Dr. Timo Hammer, CEO at Hohenstein Medical. “As we grow our biocompatibility program, we remained focused on bringing in a team that exemplifies excellence starting with care, and Katie does just that through her dedication and expertise in medical device testing and consulting.”
Prior to joining Hohenstein Medical, Brinkman served in biocompatibility roles at Cook Research Incorporated, NAMSA, Abbott and Ethicon Endo-Surgery, Inc. (a Johnson & Johnson company), where she authored numerous biocompatibility and toxicological risk assessment reports supporting global regulatory submissions. Her work spans the entire medical device lifecycle—from new product development and design changes to the European Union Medical Device Regulation (EU MDR) remediation and post-market evaluations.
“Biocompatibility is nuanced and intricate, and I am excited to join Hohenstein Medical to bring my technical experience and passion for testing excellence together with Hohenstein’s focus on individualized support in caring for customers,” Brinkman said. “I look forward to creating a program that supports customers with a hands-on approach to make the biocompatibility process as smooth as possible.”
Aiding in Brinkman’s role is her six years of experience serving as a biocompatibility subject matter expert, certification as a Biological Safety Specialist by NAMSA and deep expertise in ISO 10993 and related vertical standards.
Hohenstein is among the few medical device testing labs accredited in chemical, physical and biological safety testing, reflecting an extensive scope not commonly achieved by others in the industry. The company’s integrated approach provides consistent, efficient evaluations aligned with FDA, MDR, ISO 10993 - including ISO 10993-1 (Evaluation and testing within a risk management process), ISO 10993-12 (Sample preparation and reference materials) and ISO 10993-18 (Chemical characterization of materials) - and other global regulatory requirements.
For details on Hohenstein’s medical device services, visit Hohenstein.US/Medical
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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 chemical screenings, biological in-vitro tests and microbiological evaluations such as bioburden and barrier effectiveness. 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. Food and Drug Administration (FDA), European Medical Device Regulation (MDR), ISO-10993 and other global regulatory requirements.
Hohenstein Medical offers comprehensive consulting and testing services, including single-use and reusable products, finished devices and components, patient-contact materials and protective equipment — all tailored to the intended use, contact classification and regulatory pathway. The company’s team works in close collaboration with clients and customizes 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 services with more than 75 years of scientific experience and involvement in international standard development.
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