Medical Device Cybersecurity Requirements Under the EU MDR The European Medical Device Regulation (MDR) introduced a more rigorous approach to medical device cybersecurity, making it a safety requirement for medical devices (and IVDs under the EU IVDR). With AI making its way into the healthcare space and more devices relying on connectivity to function, hackers [...]
Oriel STAT is a New Jersey-based consulting firm that provides MDSAP auditing, QMS implementation, private team training, and related services for the medical sector.