IVDwise Information

IVD validation evidence decides whether a diagnostic reaches the market — yet most teams still assemble it across spreadsheets, disconnected statistics packages, and manual reports. The result is slow, hard to reproduce, and difficult to defend in front of a notified body or the FDA. IVDwise replaces that fragmented stack with a single, CLSI-guided workflow for analytical performance validation. From the first study design to a regulatory-ready report, every step follows recognised CLSI evaluation protocols (EP05, EP06, EP07, EP12, EP17, EP28, EP34 and more) and maps cleanly to IVDR, FDA and ISO 15189 expectations. One platform, six steps: ● Define — select the right CLSI protocol and acceptance criteria. ● Load — bring in structured study data. IVDwise can be configured to import raw data directly from the analyzer. ● Analyze — run the protocol-required statistics powered by R and validated against reference results cross-validated. ● Interpret — see results against acceptance criteria, no guesswork. ● Report — automatically generate a defensible, audit-ready output, customized to your precise requirements. ● Reuse — turn every study into reusable knowledge for the next one. Complete validation workflow stays in the tool. Built for IVD developers and manufacturers — R&D, QA/QC and technical leadership — IVDwise shortens validation timelines, reduces statistical and regulatory risk, and produces performance claims you can stand behind. Less rework. Fewer spreadsheets. Evidence that holds up. IVDwise is developed by Datancia, based in Barcelona.