Medinex

Medinex is a Netherlands-based consultancy combining medical software engineering and regulatory compliance. It supports medical device, IVD and digital-health teams with MDR and IVDR compliance across the product lifecycle. Services include software lifecycle work under IEC 62304, ISO 13485 quality systems, ISO 14971 risk management, information security and cybersecurity. The firm also advises on data privacy and governance for AI used in medical devices.