The objective of this research is to develop new forms of tool-supported safety analyses for next-generation integrated medical systems that are based on the concept of medical application platforms (MAP). A MAP is a safety- and security-critical real-time computing platform for (a) integrating heterogeneous devices, medical IT systems, and information displays via a communication infrastructure and (b) hosting application programs (”apps”) that provide medical utility via the ability to both acquire information from and update/control integrated devices, IT systems, and displays.

Abstract: Medical devices are typically developed as stand-alone units. Current industrial Verification and Validation (V&V) techniques primarily target stand-alone systems. Moreover, the US Food and Drug Administration’s (FDA) regulatory clearance processes are designed to approve such devices that are integrated by a single manufacturer with complete control over all components.

Abstract: Medical devices are typically developed as stand-alone units. Current industrial Verification and Validation (V&V) tech- niques primarily target stand-alone systems. Moreover, the US Food and Drug Administration’s (FDA) regulatory clearance processes are designed to approve such devices that are integrated by a single manufacturer with complete control over all components.