FDA perspective on virtual machines

Sandy Hedberg of SoftwareCPR reported that at the BECS conference Nov. 4-5, 2009 Brian Fitzgerald of FDA gave a presentation in which use of virtual machines was mentioned. Sandy’s synopsis is: Brian Fitzgerald of FDA discussed use of the emerging technology, of virtual machines. A virtual machine is a hardware emulation layer of an operating system providing a guest OS hosting capability. It appears that FDA’s current thinking is that they will not have issues with virtualization as long as the manufacturer has adequately addressed hazards associated with the increased complexity. However, they caution that the technology as it exists today cannot deal with a catastrophic failure of a virtual machine (no data recovery). Brian additionally felt that IEC 80001-1 could address aspects of virtualization and strongly advised manufacturers to become familiar with and participate in the development of this standard.

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