Case study · Healthcare

Every implanted device traceable to a valid certificate

A hospital procurement and compliance function required to prove, per device, that documentation was complete and current at the time of use.

The client

Who they are.

A hospital procurement and compliance function responsible for implantable devices. It must be able to show, per device, that the documentation was complete and current at the moment the device was used.

Anonymised at the client’s request. Client names are never disclosed without written permission.

22kdevice files
5documents per device
100%traceable to certificate
The task

What had to be solved.

Device documentation lived in three places — with the supplier, on the ward, and in the pharmacy. Proving compliance for a single implant meant assembling three registers, and an expired conformity declaration was invisible until an inspection found it.

The goal

What success looked like.

  • Hold one complete document set per device, checked on receipt
  • Verify certificate validity against the date of use
  • Produce compliance evidence per device on request
The solution

What Ceertia does here.

A use case for device files that checks presence of every required document and the validity of the conformity declaration against the date of use. A missing or expired document flags before the device is released from stock.

A real rule One rule, as it runs.

Every device file must hold a conformity declaration valid on the date the device was used.

The procedure

How it runs, step by step.

1
Intake

The file arrives with its documents, in any format, from whoever sends it.

Device certificatesConformity declarationsSterilisation recordsSupplier documentationLot and batch recordsImplant registry entries
2
Recognition & classification

Every page is identified and mapped against the expected document list. Missing documents, duplicates and out-of-scope pages are flagged on receipt.

3
Verification

Each rule asks the file a question and answers it directly on the documents, with page, zone and source text attached to the verdict.

4
Arbitration

The team approves, requests a fix, or rejects. No file is approved or rejected automatically.

The result

What changed.

Compliance evidence is now stored per device and exportable on request. The question "prove this implant was compliant" went from a three-register search to a lookup.

Before
  • Device documentation lived with the supplier, the ward and the pharmacy separately.
  • Proving compliance for a single implant meant assembling three registers.
  • An expired conformity declaration was invisible until an inspection.
After
  • Each device file is checked for completeness and certificate validity at the date of use.
  • A missing or expired document is flagged before the device is released.
  • Compliance evidence is stored per device, exportable on request.

Anonymised case. Client names are never disclosed without written permission. Figures describe the file volumes and checks in this scenario.

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See it run on your own files.

Bring one real file to a 30-minute demo. Watch the verification run, evidence on screen.