Consistent at unit level, but unchecked everywhere else
A label revision — a new catalogue reference, an updated IFU instruction — reliably went out correctly on the unit label. Intermediate and case-level packaging didn't always follow in the same cycle. Each level passed its own review; nothing compared the three against each other. The gap was invisible until a EUDAMED registration check or a notified body audit surfaced it.
"We were confident in the unit label. The case label was where things went quiet." — Regulatory Affairs Lead
UDI, IFU, and symbols verified together – at every level
UDI carriers at every packaging level are decoded and compared against the approved specification in the same session — unit, intermediate, and case, checked against each other and against the master. IFU content is verified character-by-character across every required language version. ISO 15223-1 symbol accuracy is confirmed through graphic comparison.
"The three packaging levels finally get checked against each other, not just against themselves." — Labeling Operations Manager
Consistency confirmed before it becomes a finding
Packaging-level mismatches are caught in the verification session, not at EUDAMED registration or during inspection. The review produces one structured deviation report and one audit trail per release, aligned with EU MDR and 21 CFR Part 11 expectations.
"We're not hoping the levels match anymore. We know." — Quality Assurance Manager
