First experiences with the implementation of the European standard EN 62304 on medical device software for the quality assurance of a radiotherapy unit

摘要

BackgroundAccording to the latest amendment of the Medical Device Directive standalone software qualifies as a medical device when intended by the manufacturer to be used for medical purposes. In this context, the EN 62304 standard is applicable which defines the life-cycle requirements for the development and maintenance of medical device software. A pilot project was launched to acquire skills in implementing this standard in a hospital-based environment (in-house manufacture).