Using UML Profile and OCL to Impose Regulatory Requirements on Safety-Critical System

Design a Safety critical system that satisfies all regulatory requirements is a challenging issue facing the software engineering community. In the medical systems industry, all medical devices must pass the FDA pre-market review before a new product can be deployed to the market because the FDA regulators need to ensure such new products are safe and reliable. Therefore, how to evaluate if a medical system satisfies all regulatory requirements becomes an important issue in the medical device industry. In this paper, we propose a novel profile which imposes the regulatory requirements for the generic insulin infusion pump (GIIP) example. This profile can be applied to different designs to aid the system designers in validating whether the specific design considers the regulatory requirements or not. The main contribution of our approach is that, we help the insulin infusion manufacturers to consider all the relevant regulatory requirements and also provide a mechanism for further validation. Once we deploy our profile to the industry, the insulin infusion pump manufacturers can validate whether their designs consider all the regulatory requirements. This is a fundamental step towards further validating whether a design satisfies the FDA regulatory requirements on the generic insulin infusion pump.