Background: According to the latest amendment of the Medical Device Directive standalone software qualifies as\r\na medical device when intended by the manufacturer to be used for medical purposes. In this context, the EN\r\n62304 standard is applicable which defines the life-cycle requirements for the development and maintenance of\r\nmedical device software. A pilot project was launched to acquire skills in implementing this standard in a\r\nhospital-based environment (in-house manufacture).\r\nMethods: The EN 62304 standard outlines minimum requirements for each stage of the software life-cycle, defines\r\nthe activities and tasks to be performed and scales documentation and testing according to its criticality. The\r\nrequired processes were established for the pre-existent decision-support software FlashDumpComparator (FDC)\r\nused during the quality assurance of treatment-relevant beam parameters. As the EN 62304 standard implicates\r\ncompliance with the EN ISO 14971 standard on the application of risk management to medical devices, a risk\r\nanalysis was carried out to identify potential hazards and reduce the associated risks to acceptable levels.\r\nResults: The EN 62304 standard is difficult to implement without proper tools, thus open-source software was\r\nselected and integrated into a dedicated development platform. The control measures yielded by the risk analysis\r\nwere independently implemented and verified, and a script-based test automation was retrofitted to reduce the\r\nassociated test effort. After all documents facilitating the traceability of the specified requirements to the\r\ncorresponding tests and of the control measures to the proof of execution were generated, the FDC was released\r\nas an accessory to the HIT facility.\r\nConclusions: The implementation of the EN 62304 standard was time-consuming, and a learning curve had to be\r\novercome during the first iterations of the associated processes, but many process descriptions and all software\r\ntools can be re-utilized in follow-up projects. It has been demonstrated that a standards-compliant development of\r\nsmall and medium-sized medical software can be carried out by a small team with limited resources in a clinical\r\nsetting. This is of particular relevance as the upcoming revision of the Medical Device Directive is expected to\r\nharmonize and tighten the current legal requirements for all European in-house manufacturers.
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