Medical devices and diagnostics
Every device is an individual with a history — where it was, who holds it, whether its warranty is live, whether it was recalled — and the regulator expects that history on demand.
The things we hear most in this trade.
- “A device came back and we can't tell if it's the one we shipped.
- “Warranty starts when we shipped, not when the hospital bought it, so we lose money.
- “A recall means calling every customer by hand.
- “Counterfeits carry our serials.
Capability, and the outcome it buys you.
Two life stories per unit — identity (allocated, commissioned, retired) and physical journey (in stock, reserved, picked, packed, shipped, delivered, returned, quarantined, recalled, scrapped)
a returned-and-restocked device never looks new.
Units nest into inner packs, cases and pallets; a dock check reports exactly which units are missing or don't belong
shipments are verified, not assumed.
Serial blocks issued by a regulator, a brand-owner customer or pre-printed labels, with no possibility of two lines stamping the same serial
identity is unique by construction.
Anyone scanning a code gets one of seven verdicts (valid, not found, suspect, recalled, expired and more) with reasons; every check is logged; suspected counterfeits go to an investigation lane
authentication at the point of use.
Warranties start at the customer's actual purchase date, follow the unit on resale or void per policy, support annual-maintenance renewals; a warranty desk tracks claims through repair, replacement, parts and cost
warranty is a ledger, not a guess.
Recall campaigns with regulator reference, class, scope, e-signed announce and close, a holder roster and a daily recovery curve
a recall runs itself.
Label printing produces byte-identical output with a full print and reprint log; a unit passport merges everything that ever happened to it
the regulator's question is one screen.
Non-conformances, complaints with injury and reportable-event flags and duplicate detection, corrective actions with effectiveness checks, risk analysis with risk priority numbers
post-market surveillance is built in.
GS1 EPCIS event exchange with distributors and hospitals; DSCSA and EU-FMD serialisation
the standards file is a click.
An infusion pump is serialised inside its batch, cased and shipped to a hospital; delivery sets the warranty start. Eleven months later it comes back for service: the scan shows lot, case, pallet, quality results, warranty status and no recall. A complaint on a sister unit flags a reportable event, opens a non-conformance, and a risk review raises the failure mode's priority. When the regulator asks for the unit's history, the passport is exported as a standards-based event file.
The standards and regulations this industry answers to.
- FDA 21 CFR Part 11
- DSCSA (US)
- EU-FMD and UDI
- GS1 GTIN/SSCC/EPCIS
- ISO 2859-1 sampling
- CDSCO device rules (India)
Talk to us about medical devices.
Bring the hardest thing you have had to prove — the lot that failed, the return nobody could place, the audit that cost you a week. That is the demo.