Predictable quality is a key aspect of today's complex medical devices. The Summer Software Symposium: Assuring Confidence in Predictable Quality of Complex Medical Devices will explore the requirements of different stakeholders for predictability and discuss some techniques for demonstrating confidence in the assurance of quality that may be useful in satisfying these requirements.

Procurers of medical devices need confidence that the medical devices they buy have predictable reliably and will be available when they are needed. Developers of medical devices need confidence that they can predictably demonstrate quality. They need to predict how much verification and validation will be needed and when it will be completed. Regulators of medical devices need confidence that the device is safe and performs as claimed by the manufacturer, and that their review can be completed to meet statutory schedule requirements. Techniques for demonstrating assurance that a medical device satisfies its quality objectives will be explored to determine whether these techniques can be used to provide increased predictability in device quality, as well as development and approval schedules.