White Papers - FPGA
Best practice development processes for medical device FPGAs
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.
Understanding DO-254 and Solutions to Facilitate Compliance
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.
Enabling Model-Based Design for DO-254 Compliance with MathWorks and Mentor Graphics Tools
DO-254 compliance is becoming increasingly common on commercial and military aviation projects. Companies often struggle with the requirements and costs of DO-254 compliance. Engineers can use Model-Based Design for requirements analysis, design, automatic HDL code generation, and verification to produce airborne electronic hardware that adheres to DO-254. Model-Based Design for DO-254 combines automation tools from MathWorks and Mentor Graphics for design and verification to support a development process that goes from concept through implementation. This paper discusses this flow.
Using ReqTracer to Facilitate a Requirements-Driven DO-254 Compliant Design
This paper discusses the DO-254 principle of requirements traceability and describes how a new tool, ReqTracer™, can assist with the challenge of establishment of a requirements-driven design flow by simplifying the process and lowering project costs.
DO-254 is a new challenge facing aerospace companies and, in some cases, companies serving other safety- and mission-critical markets. A key element of DO-254 programs is the establishment of a requirements-driven design flow.
DO-254 Compliance: Reducing Project Cost by Avoiding Common Pitfalls
Many folks stumble on very similar issues when they begin their journey towards creating and executing DO-254 compliant design projects. The good news is that each of these issues has solutions. Understanding these common pitfalls, and proactively addressing them before they cost a project time, resource and certification risk, is essential. Some of these common pitfalls, along with advice for addressing them (based on learnings from successful DO-254 programs), are described in this paper.