“…Quality management standards, such as ISO 13485, where the regulatory requirements for medical device development are defined, and ISO 14971, where management of risk associated with a device is defined, drive most large organizations to develop their own quality management and risk evaluation processes (Bernardo, Casadesus, Karapetrovic & Heras, 2012; Guijarro, López-Rodríguez, Moral, Mena & Álvarez, 2012; Ullmann et al, 2013; Westgard, 2013). Returns from creating such a synergistic system can further be mapped in terms of patient experience, staff experience or even the impact on the bottom line for the equipment manufacturer and using organization (Bernardo, Casadesus, Karapetrovic & Heras, 2008; Jørgensen, Remmen & Mellado, 2006; McCarthy et al, 2016; Zeng, Shi & Lou, 2007).…”