Software systems are becoming increasingly complex. Withinsafety critical domains such as medical device software, thisincreasing complexity is placing growing demands onmanufacturers who must ensure their software not only meetsfunctional requirements but is also safe and reliable. However, theFood and Drugs Administration who regulate medical devicesoftware in the United States report a significant increase inrecalls between years 2003 and 2012 and have cited softwaredifficulties as one of the frequent causes of recalls. Furthermore arecent analysis of traceability documentation submitted to theAdministration has revealed that the traceability data wasincomplete, incorrect, and conflicting in many cases. This isproblematic as traceability plays an important role in thedevelopment of safe and reliable software. In this paper wepresent the validation, through industry trial, of a traceabilityassessment and implementation framework which we havedeveloped to assist medical device organizations implementtraceability in an efficient and regulatory compliant manner. Ourfindings show that implementation of the framework within twoorganizations improved their traceability process and that bothorganizations found the framework to be both useful and usable.