Björn-Carsten Schüre is an expert in biological safety of medical devices with a background in regulatory affairs and technical documentation in accordance with the MDR and IVDR. He supports manufacturers in biocompatibility evaluations, risk management activities in accordance with ISO 14971, and the planning and assessment of PMS and PMCF activities. His background combines academic qualifications in bio- and nanotechnology as well as molecular and applied biotechnology.
Blog Post by Björn-Carsten Schüre - Expert Biological Safety
