Noordmans Regulatory Consulting B.V. is operating independently in the medical device field. We have expertise relevant for medical device manufacturers and its suppliers. We can support you during design and development of medical devices as well as post market. We implement Medical Device Regulations, set up, write and maintain Technical Dossiers and Design History Files, product risk and security life cycle, software development, usability engineering,  basic safety & essential performance and electromagnetic disturbances. Activities are executed according to your Quality Management System (ISO 13485), also including for example the requirements of the EU MDR/IVDR and of the FDA (21 CFR Part 820).