Figure 1From: First experiences with the implementation of the European standard EN 62304 on medical device software for the quality assurance of a radiotherapy unitRelationship of EN 62304 to other standards. Compliance with the EN 62304 standard requires a quality management system, a risk management system and the application of usability engineering. Adherence to the applicable standards results in a presumption of conformity with the Medical Device Directive.Back to article page