Jan-Oliver Hollnagel

Senior Clinical Evaluator at BIOTRONIK

Speaker

Jan-Oliver Hollnagel is a senior clinical evaluator in the regulatory affairs team at BIOTRONIK. He oversees key stages of the clinical evaluation process, including the collection, appraisal, and analysis of clinical data to demonstrate compliance with the MDR’s general safety and performance requirements. Jan-Oliver primarily works on high-risk Class III medical devices, which require rigorous and continuous clinical evaluation, including systematic literature screening. His searches range from rather broad reviews of the state of the art in cardiac rhythm management to highly focused device-specific queries aimed at monitoring safety and performance.

Given the volume and complexity of these searches, Jan-Oliver is passionate about leveraging smart algorithms and AI-driven tools to streamline workflows and accelerate evaluations while ensuring that human expertise remains central to decision-making. Holding a PhD in Medical Neurosciences, he values the flexibility and depth of human intelligence in complementing advanced technologies.