A practical workshop providing a clear overview of 21 CFR Part 11 regulation and its application in software development. Participants learn how to assess systems, identify missing features, and plan technical and documentation updates that align with FDA expectations. The workshop covers key concep...
Manufactured by
BioSistemika
Slovenia
Custom Software for Medical Diagnostics and IVD. BioSistemika is a specialized software development partner for medical diagnostics and IVD companies, supporting the development and evolution of software for diagnostic instruments, platforms, and digital ecosystems. We combine deep life sciences expertise.
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