Hohenstein Medical, a Hohenstein Labs division that provides testing, research, and certification services for medical devices, has named Katie Brinkman as its biocompatibility program manager.

Brinkman will lead development and strategic positioning of the company’s device compatibility program, focusing on chemical characterization, ISO 18562 gas pathway testing and ethical, non-animal assays. She will also offer biocompatibility consulting, which includes biological evaluation plans and reports.

Before joining Hohenstein Medical, Brinkman was in biocompatibility roles at Cook Research Incorporated, NAMSA, Abbott, and Ethicon Endo-Surgery (a Johnson & Johnson company). During her tenures, she authored several biocompatibility and toxicological risk assessment reports to support regulatory submissions around the world.

Brinkman’s work covers the whole medical device lifecycle: from new product development and design changes to the European Union Medical Device Regulation (EU MDR) remediation and post-market evaluations. Supporting her role is six years of experience as a biocompatibility subject matter expert, certification as a Biological Safety Specialist by NAMSA and deep expertise in ISO 10993, and related vertical standards.

“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 Hohenstein Medical CEO Dr. Timo Hammer. “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.”

The company is a medical device testing lab accredited in chemical, physical and biological safety testing. Its approach aligns 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.

“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.”