By a News Reporter-Staff News Editor at Clinical Oncology Week -- A new study on Therapeutics is now available. According to news reporting from Heidelberg, Germany, by NewsRx journalists, research stated, "According 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."
The news correspondents obtained a quote from the research from German Cancer Research Center, "A pilot project was launched to acquire skills in implementing this standard in a hospital-based environment (in-house manufacture). The EN 62304 standard outlines minimum requirements for each stage of the software life-cycle, defines the activities and tasks to be performed and scales documentation and testing according to its criticality. The required processes were established for the pre-existent decision-support software FlashDumpComparator (FDC) used during the quality assurance of treatment-relevant beam parameters. As the EN 62304 standard implicates compliance with the EN ISO 14971 standard on the application of risk management to medical devices, a risk analysis was carried out to identify potential hazards and reduce the associated risks to acceptable levels. The EN 62304 standard is difficult to implement without proper tools, thus open-source software was selected and integrated into a dedicated development platform. The control measures yielded by the risk analysis were independently implemented and verified, and a script-based test automation was retrofitted to reduce the associated test effort. After all documents facilitating the traceability of the specified requirements to the corresponding tests and of the control measures to the proof of execution were generated, the FDC was released as an accessory to the HIT facility. The implementation of the EN 62304 standard was time-consuming, and a learning curve had to be overcome during the first iterations of the associated processes, but many process descriptions and all software tools can be re-utilized in follow-up projects. It has been demonstrated that a standards-compliant development of small and medium-sized medical software can be carried out by a small team with limited resources in a clinical setting."
According to the news reporters, the research concluded: "This is of particular relevance as the upcoming revision of the Medical Device Directive is expected to harmonize and tighten the current legal requirements for all European in-house manufacturers."
For more information on this research see: First experiences with the implementation of the European standard EN 62304 on medical device software for the quality assurance of a radiotherapy unit. Radiation Oncology, 2014;9():1-10. Radiation Oncology can be contacted at: Biomed Central Ltd, 236 Grays Inn Rd, Floor 6, London WC1X 8HL, England. (BioMed Central - www.biomedcentral.com/; Radiation Oncology - www.ro-journal.com)
Our news journalists report that additional information may be obtained by contacting A. Hoss, German Canc Res Center, Div Med Phys Radiat Oncol, D-69120 Heidelberg, Germany. Additional authors for this research include C. Lampe, R. Panse, B. Ackermann, J. Naumann and O. Jakel (see also Therapeutics).
Keywords for this news article include: Europe, Germany, Software, Heidelberg, Radiotherapy, Therapeutics
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