For FPGA developers working on designs for medical devices, one approach to dealing with regulatory uncertainty is to borrow heavily from design assurance processes in other safety-critical industries, such as avionics, where standards are well established. These well-established standards mandate a development flow that is controlled, auditable and perhaps most important, specific to the requirements of hardware engineering. While following such a flow will not guarantee smooth sailing though every regulatory approval process for FPGA devices bound for medical applications, it is consistent with basic regulatory intent – to demonstrate to auditors that complex devices meet their requirements and perform well under all foreseeable conditions.