White Papers - FPGA

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.

RTCA/DO-254 (also known as DO-254 in the US or ED-80 in Europe) provides guidelines to facilitate requirements-based design of airborne electronic hardware. Now mandated by the US Federal Aviation Association (FAA) and many other aviation agencies and military programs, DO-254 establishes a standard to ensure that airborne custom micro-coded components (i.e., PLD, FPGA, and ASIC devices) perform their intended function under all foreseeable conditions.

First attempts to comply with DO-254 standards can be fraught with delays and unexpected costs. Project managers can minimize these difficulties if they understand what DO-254 compliance really entails, and modify their flows and toolsets to support it.