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 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.
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