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.

Dr.