Medical Devices conference, held in Munich, Germany on 28-29 January, was filled with sessions that dug into the minutiae of ...
Functionality in the device firmware sends patient data to a hardcoded IP address that also downloads and executes binary ...
For those with Class IIa or above AI-related devices, compliance with the EU’s AI Act is likely to be akin to the EU MDR.
The classification of medical devices are done at the state ... because their interpretation of the risk were different from the device manufacturers. Now, that ambiguity has been addressed ...