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@ARTICLE{Hss:120694,
      author       = {A. Höss and C. Lampe and R. Panse and B. Ackermann and J.
                      Naumann and O. Jäkel$^*$},
      title        = {{F}irst experiences with the implementation of the
                      {E}uropean standard {EN} 62304 on medical device software
                      for the quality assurance of a radiotherapy unit.},
      journal      = {Radiation oncology},
      volume       = {9},
      number       = {1},
      issn         = {1748-717X},
      address      = {London},
      publisher    = {BioMed Central},
      reportid     = {DKFZ-2017-01120},
      pages        = {79 -},
      year         = {2014},
      abstract     = {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. 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. 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.},
      cin          = {E040},
      ddc          = {610},
      cid          = {I:(DE-He78)E040-20160331},
      pnm          = {315 - Imaging and radiooncology (POF3-315)},
      pid          = {G:(DE-HGF)POF3-315},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:24655818},
      pmc          = {pmc:PMC3994433},
      doi          = {10.1186/1748-717X-9-79},
      url          = {https://inrepo02.dkfz.de/record/120694},
}