Dr. Julia Bubeck is an expert in regulatory affairs, technical documentation, and biological and clinical evaluation of medical devices. She supports manufacturers in developing regulatory strategies, as well as in biocompatibility evaluation in accordance with ISO 10993, the preparation of risk management files in accordance with ISO 14971, and clinical evaluation in accordance with the MDR and MEDDEV 2.7/1 Rev. 4. Her expertise is grounded in a doctorate in biology and extensive project experience in regulatory affairs and technical documentation.
Blog Post by Dr. Julia Bubeck - Head of Operations
