Rutger Flink
Rutger Flink is a professional with a deep passion for the medical device industry, finding it to be one of the most exciting markets due to the potential to enhance patient care and outcomes. With a strong background in product development, Rutger has amassed valuable expertise in various areas such as design control, biocompatibility tests, clinical investigations, process validation, and risk management. He has a solid track record of ensuring compliance with quality management systems according to ISO 13485:2016 and FDA 21 CFR Part 820 (QSR). Rutger's collaboration with renowned academic institutions and his current Ph.D. position offer him valuable clinical perspectives to innovate in the critical care domain. His involvement as a Dutch norm committee member for clinical research of medical devices (ISO 14155:2020) blends his proficiency in medical product development and clinical investigations. Rutger's commitment to knowledge sharing led him to establish BMEPortal.com, a platform aimed at aiding Biomedical Engineers by facilitating industry connections and offering educational resources on regulatory standards.