10 Key EU MDR Cybersecurity Requirements for Medical Devices
In the modern healthcare system, every connected device can be a potential entry point for hackers. Protecting these systems ensures that innovative digital medical devices remain safe, reliable, and trusted. Hence, cybersecurity is vital in the medical device...
5 EU MDR Medical Device Software (MDSW) Requirements
EU MDR defines medical device software (MDSW) as a software with medical purpose, whether standalone or embedded in a device. MDSW is regulated as an active medical device. Its classification is primarily determined by Rule 11 of Annex VII. Most diagnostic or...
Roles of Person Responsible for Regulatory Compliance (PRRC)
Person Responsible for Regulatory Compliance (PRRC) is a mandatory requirement under Article 15 of the EU Medical Device Regulation (MDR). It requires manufacturers and authorized representatives to appoint a qualified individual with expertise in regulatory affairs...