Medical Device Regulatory EU MDR, CE, FDA, MHRA, UKCA, ISO 13485 specialist
United States
English, German, Italian, French
About me
I help medical device companies navigate regulatory requirements and prepare practical, audit-ready compliance documentation for global market access. My focus includes EU MDR, CE marking, UKCA, MHRA, FDA, ISO 13485, ISO 14971, EUDAMED, technical documentation, risk management, labeling, PMS and regulatory submissions. I work with startups, manufacturers and international businesses to identify compliance gaps, organize documentation and build clear regulatory pathways.... Read more