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Medical device traceability

Traceability that holds up to an inspection.

ZMedPri-1 Article 12 requires a UDI record for notified-body-certified devices. Inventura links receiving, checks, lot, expiry and responsible person into one record.

In development. For clinics, laboratories and other health institutions.

A delivery in a clinic storeroom: an open box of sterile pouches, hands scanning a barcode on a carton with a phone, and an ordered shelf of labelled stock behind.

One day, one box

Every movement is recorded. With no extra work.

The example below follows one box of composite through a working day.

Illustration of an inspection pack: stacked cartons with barcode labels, a binder, a clipboard and a scanner.

The item on record

Composite A2, lot L4472B

Elapsed08:14 — 14:39

  1. 08:14ReceivedScan the label with a camera or scanner. Inventura resolves the product and fills in the data carried by the code; you enter the quantity.
  2. 09:02Receipt checkThe checklist follows your procedure. The record keeps who performed the check, what they found and when.
  3. 11:30On the shelfInventura tracks stock by storage place and lot; each lot has its own expiry. It blocks an expired item or requires an explicit write-off or override decision.
  4. 14:37RecallThe manufacturer publishes a recall for a UDI-DI and lot. Enter both, and Inventura shows the affected stock, storage places and movements.
  5. 14:39Inspection packA point-in-time export, ready for an inspection.

Underneath

Simple on top, evidential underneath.

Staff do not maintain an audit trail. Staff scan. The trail forms below that.

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