More on EU medical devices cybersecurity regulation

In a previous post I promised more on cybersecurity, so here it is. Spoiler alert: the conclusion of this post is that cyber security requirements for medical devices in Europe are currently an overlapping patchwork of different statutes with little attention for system and network security. So the conclusion is: there is nothing specific, except the security requirements in the EN 62304 harmonized standard for Medical device software — Software life-cycle processes. Compared to what the FDA is currently [...] « Read the rest of this article on medicaldeviceslegal »