Medical device manufacturing
Medical device manufacturers (Class II/III, ISO 13485) carry UDI and GUDID identity plus both lot and serial traceability down to the order and shipment line, often with configure-to-order catalogs for variants and kits. Traceability is a regulatory backbone, not a feature.
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The reality in medical device manufacturing
- 1
UDI and GUDID device identity plus lot and serial traceability must flow to order and shipment lines.
- 2
Configure-to-order catalogs cover device variants and kits.
- 3
Regulatory documentation (instructions for use, regulatory status) attaches per product.
- 4
ISO 13485 quality processes constrain change control and recordkeeping.
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Other medical & healthcare supply verticals
Questions buyers ask
What does a medical device manufacturer need that generic B2B lacks?
Device identity and dual traceability. UDI and GUDID identifiers plus lot and serial numbers have to flow all the way to the order and shipment line, and the catalog often has to configure variants and kits. This is regulatory infrastructure the platform has to model, not bolt on.
Why both lot and serial traceability?
Because devices are tracked at both levels for recalls and field actions. Lot covers a production batch; serial identifies the individual unit. Tying both to the order means a manufacturer can trace any device from shipment back to its build, which Class II/III work requires.