I&#x27;m just curious.  I work in the automotive sector and develop hardware and software using components that are advertised as functionally safe.  I use harden RTOS from vendors who claim their RTOSes are in medical devices as well as military systems.<p>One such system is Disti (<a href="http:&#x2F;&#x2F;www.disti.com&#x2F;" rel="nofollow">http:&#x2F;&#x2F;www.disti.com&#x2F;</a>)<p>In the automotive field, our software is MISRA compliant, static analysis is done (Klockworks - <a href="http:&#x2F;&#x2F;www.klocwork.com&#x2F;" rel="nofollow">http:&#x2F;&#x2F;www.klocwork.com&#x2F;</a>) and we follow a very strict set of guidelines outlined in ISO25119 and ISO26262 for the construction and agricultural markets.  Think self driving tractors and combines.  For example: A tractor traveling down a field with a combine following it a few rows over separating and chopping things into a catcher all done with one person driving.<p>This shit can&#x27;t happen where I work.  Every component on our circuit boards has a MTTFd of 40 years.  Hardware watchdogs can kill the system if software goes awry.<p>Software is written to readiness level called SRL-1, SRL-2, etc... Unit tests, peer reviews, etc... Functional safety in medical devices is covered under 510(K)
(<a href="http:&#x2F;&#x2F;www.fda.gov&#x2F;MedicalDevices&#x2F;ProductsandMedicalProcedures&#x2F;DeviceApprovalsandClearances&#x2F;510kClearances&#x2F;" rel="nofollow">http:&#x2F;&#x2F;www.fda.gov&#x2F;MedicalDevices&#x2F;ProductsandMedicalProcedur...</a>)<p>I find it amazingly short sited that antivirus software is even allowed on a medical device to begin with.  I can&#x27;t even imagine how this system even passed the easiest audit for software readiness.<p>How is it you &quot;go hoarse having the same conversations?&quot;  Do you not have to meet FDA compliance criteria?  Are you in the US?<p>I didn&#x27;t read the whole article so I&#x27;m assuming this happened in the US.  For me, we sell autonomous vehicles in the European markets where functional safety seems to be a bit more aggressive there right now for vehicles.  Not sure about medical devices.