FDA’s draft guidance on cybersecurity: nothing exciting but useful examples

These days I am more and more involved in medical devices software matters: interesting questions about modularisation, whether or not EHRs are medical devices in Europe and negotiation of systems integration agreements within the systems integration clause of the EU medical devices directive, just to mention a few. But so far I have not really been dealing with any in-depth questions from clients regarding connected device security. No wonder that I was interested to see that the FDA released a draft guida [...] « Read the rest of this article on medicaldeviceslegal »