Transforming requirements of IEC 80001-1 into an ISO/IEC 15504-2 compliant process reference model and process assessment model

Efficiencies in patient care can be achieved through interoperability of medical devices. Patient safety is the key concern during the design and manufacture of medical devices with medical devices being subject to stringent regulation in the region in which the device is to be marketed. However, with medi-cal devices increasingly being designed to be incorporated into an IT network, the process of network-ing the device can introduce risks that may not have been considered during the design and manufac-ture stage. IEC 80001-1 was developed to address the risks associated with the incorporation of a medical device into an IT network. This paper presents how the requirements of IEC 80001-1 were used to develop a Process Reference Model (PRM) and Process Assessment Model (PAM) which are compliant with the requirements for PRMs and PAMs as outlined in ISO/IEC 15504-2.