Insulin Pump Software Certification.

The insulin pump is a safety-critical embedded medical device used for treatment of type 1 and insulin treated type 2 diabetes. Malfunction of the insulin pump will endanger the user's life. All countries impose some regulation on the sale and use of medical devices. The purpose of such regulation is to protect the public by imposing standards of safety for medical devices, including insulin pumps. The regulator in the USA, the USA Food and Drug Administration FDA, actually goes further, and includes efficacy in the regulatory requirement. Until recently, regulatory approval was dependent on process based guidance. However, this has proven to be inadequate in some most cases where the device depends on software for its safe and effective operation, and the FDA recently changed its approval process for infusion pumps including insulin pumps, so that the production of an assurance case that demonstrates that the device is safe and effective is now a strongly suggested regulatory requirement. However the current regulatory guidance does not recommend any particular software development methodology, and does not include definitive guidance on the evaluation component of the certification process. In this paper, we briefly review the related USA regulatory standards for insulin pumps, highlight development and certification challenges, briefly discuss attributes of a safe, secure and dependable insulin pump, and propose an effective certification process for insulin pumps.