Mr Leon Doorn

egulatory, Quality and Information Security expert in the field of medical devices. Experience with implementing: - Quality Management systems per ISO 13485 - Information Security Management systems Per ISO 27001 - Regulatory Affairs per MDR, Health Canada, FDA, and acting as PRRC - Privacy Regulations per GDPR (2016/679), and acting as DPO Additional knowledge and understanding of the current field of standards around software medical devices, and those enabled by AI (i.e. deep-learning technology).