??? 09/13/05 14:12 Read: times |
#101004 - Same for the FDA and EU regulatory Responding to: ???'s previous message |
FDA (and EU) doesn't care what you make or select as long as it's safe and effective (tested and documented). You can use a buggy version of Windows 3.11 as the OS for your life supporting device as long as you ensure that it's safe and meets all specs.
Bruce |