IVDCheckR - Simplifying documentation for laboratory developed tests according to IVDR requirements by introducing a digital tool

This tool is a guide for documentation for laboratory developed tests according to IVDR requirements. It further provides quick solution for routine clinical laboratory calculations such as method comparison and quality control assessment.

Official website

https://kc.uol.de/ivdcheckr/

Packages used

• shiny (https://cran.rproject.org/web/packages/shiny/index.html)
• shinydashboard (https://cran.r-project.org/web/packages/shinydashboard/index.html)
• rhandsontable (https://cran.r-project.org/web/packages/rhandsontable/index.html)
• fresh (https://cran.r-project.org/web/packages/fresh/index.html)
• shinyjs (https://cran.r-project.org/web/packages/shinyjs/index.html)
• rmarkdown (https://cran.r-project.org/web/packages/rmarkdown/index.html)
• pagedown (https://cran.r-project.org/web/packages/pagedown/index.html)
• pdftools (https://cran.r-project.org/web/packages/pdftools/index.html)
• mcr (https://cran.r-project.org/web/packages/mcr/index.html)
• tinytex (https://cran.r-project.org/web/packages/tinytex/index.html)
• shinycssloaders (https://cran.r-project.org/web/packages/shinycssloaders/index.html)
• knitr (https://cran.r-project.org/web/packages/knitr/index.html)
• digest (https://cran.r-project.org/web/packages/digest/index.html)
• htmlwidgets (https://cran.r-project.org/web/packages/htmlwidgets/index.html)

Publication

IVDCheckR has been peer-reviewed and published in the journal of Clinical Chemistry and Laboratory Medicine (CCLM). The publication describes the development, validation, and application of this digital tool for IVDR-compliant documentation of laboratory developed tests.

Access the publication: https://www.degruyterbrill.com/document/doi/10.1515/cclm-2024-0477/html

If you use IVDCheckR in your work, please cite our publication.

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