Posts by officialchicken 3 publicly visible posts • joined 28 Apr 2015
Kinda is -not- for really for you, but you can see what the biggies are doing. It is definitely for buyers of 100's to 10,000's of servers/quarter - where density counts - and the combo of software defined networking/storage and virtualization is how you orchestrate your datacenter.
Yes, a 510K is required for a device like this (Class-III) prior to sale and use.
No, the FMEA would not necessarily outline risks due to network intrusion (but it'd be insane not to). It's up to the engineers to identify the risks, and if they don't have a security background ... well, no risks will be identified much less development of a mitigation strategy (like requiring VPN).
There is no required security auditing of medical software by anyone at any time. IME, properly managing a firewall is a bit beyond the typical knowledge level and skill of the people writing the code running these devices.
The Register 
Biting the hand that feeds IT
Copyright. All rights reserved © 1998–2025
