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Episode 246 | Katie Brinkman, Biocompatibility Program Manager at Hohenstein | Navigating Biocompatibility in MedTech
In this episode, Duane Mancini sits down with Katie Brinkman to discuss the nuances of biocompatibility, the critical role of biological evaluation plans, and the evolving regulatory landscape, including the importance of risk assessment. Katie also shares her experience with biocompatibility evaluation during significant regulatory changes such as EU MDR remediation and the 10993 standard updates. Katie Brinkman LinkedIn Hohenstein Website Hohenstein Group LinkedIn Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law and JumpStart Inc.
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