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With the arrival of the IVDR, and the need for audits on bioinformatics by an accreditation body authorities such as the Raad voor Accreditatie, there was a need for a field standard for bioinformatics, as from the ISO-15189 it is unclear what to audit for bioinformatics. This field standard has been initiated by Hanneke van Deutekom, member of the quality committee of the VKGL and technical assessor bioinformatics at the Raad voor Accreditatie.

Bioinformaticians from all the genetic medical laboratories in the Netherlands gathered to discuss the processes used to develop software. The processes within the different centers and the IEC-62304 were used as a guidance to create this field standard for bioinformatics.

The following people were involved with writing and reviewing.

  • Tobias Beers, Department of Pathology, Antoni van Leeuwenhoek – Netherlands Cancer Institute (AvL-NKI), Amsterdam, the Netherlands
  • Roxane E. Boyer, Department of Human Genetics, Amsterdam University Medical Center, Amsterdam, the Netherlands
  • Hanneke W. M. van Deutekom, Department of Genetics, University Medical Center Utrecht, Utrecht, the Netherlands
  • Robert F. Ernst, Department of Genetics, University Medical Center Utrecht, Utrecht, the Netherlands
  • Geert Geeven, Department of Clinical Genetics, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands
  • Bart de Koning, Department of Clinical Genetics, Maastricht University Medical Center+, Maastricht, the Netherlands
  • Thomas Leenders, Department of Human Genetics, Radboud University Medical Center, Nijmegen, the Netherlands
  • Rick Medemblik, Department of Human Genetics, Amsterdam University Medical Center, Amsterdam, the Netherlands
  • Pieter Neerincx, Department of Genetics, University Medical Center Groningen, Groningen, the Netherlands
  • Ruben H.P. Vorderman, Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands

You can provide feedback for this field standard, or leave comments or suggestions for improvement by filing an issue, which is open to everybody.

The first version was released in April 2024, the date last modified will be present on the bottom of each page.