IVDCheckR – simplifying documentation for laboratory developed tests according to IVDR requirements by introducing a new digital tool
Our Shiny web application-based platform is a digitised, user-friendly tool that simplifies the documentation for LDTs according to IVDR requirements with special emphasis on solutions for handling modifications to CE-marked assays.
Authors
- Astrid Petersmann (ORCID: https://orcid.org/0000-0001-9843-2263)
- Gunnar Brandhorst (ORCID: https://orcid.org/0009-0005-6824-7848)
- Folker Spitzenberger (ORCID: https://orcid.org/0000-0001-9434-0599)
- Daniel Rosenkranz (ORCID: https://orcid.org/0000-0002-5978-4685)
- Yadwinder Kaur
- Anna Bloemer
- Ozan Aykurt
Institutions
- Universitätsmedizin Greifswald (DE)
- Technical University of Applied Sciences Lübeck (DE)
- Fraunhofer-Einrichtung für Individualisierte Medizintechnik (DE)
Publication Details
- Journal
- Clinical Chemistry and Laboratory Medicine (CCLM)
- Published
- 2024-08-23
- DOI
- https://doi.org/10.1515/cclm-2024-0477
- Primary Topic
- Electrical and Bioimpedance Tomography
- Type
- article
- Field-Weighted Citation Impact
- 0.00