Process-based derivation of requirements for medical devices

One goal of medical device certification is to show that a given medical device satisfies its requirements. The requirements that should be met by a device, however, depend on the medical processes in which the device is to be used. Such processes may be complex and, thus, critical requirements may be specified inaccurately or incompletely, or even missed altogether. We are investigating a requirement derivation approach that takes as input a model of the way the device is used in a particular medical process and a requirement that should be satisfied by that process. This approach tries to produce a derived requirement for the medical device that is sufficient to prevent any violations of the process requirement. Our approach combines a method for generating assumptions for assume-guarantee reasoning with one for interface synthesis to automate the derivation of the medical device requirements. The proposed approach performs the requirement derivation iteratively by employing a model...

• Type: Journal
• Year: 2010
• Where: IHI
• Authors: Heather M. Conboy, George S. Avrunin, Lori A. Clarke
• Keywords: Healthcare, IHI 2010, Medical Devices, Medical Processes, Requirements