Tag: EUDAMED

All the articles with the tag "EUDAMED".

• A Theoretical Basis for Modeling the EUDAMED Domain

  7 Feb, 2025

  A theoretical basis for modeling the EUDAMED domain: a real entity, an MDR-defined role and a EUDAMED record are three separate sorts, not one thing under different names, grounded in foundational ontology, institutional-fact theory and compliance theory.