Medical device packaging is a compliance question before it is a design question — substrate declarations, batch traceability, structure that survives sterilization handling, and inspection evidence. Allen Paper Products has produced device and diagnostic packaging for brands across 80+ countries since 1998, from MOQ from 100 pcs for qualification runs to full-scale supply.
What we build for medical and diagnostic brands
Test kit and diagnostic boxes
Folding cartons and rigid boxes for test kits, with die-cut inserts that hold vials, strips and instruction cards in fixed positions. The insert is drawn on the dieline so every component has a seat — which is what prevents damage claims and makes assembly-line packing fast.
Disposable supply boxes
High-volume cartons for disposable supplies, printed with lot and expiry fields. We confirm the print area and variable-data placement before tooling, because retrofitting a batch-number field after tooling means a new plate and a new die.
Home-use device boxes
Retail-facing boxes for home devices — the pack has to explain the product on shelf and protect it in transit. Window options and diagram panels are drawn with the quick-start card in mind, so the box and the insert tell one story.
Accessory and spare-part kits
Magnetic or drawer boxes for accessory kits and spares, with trays cut to the component profile. Frequently paired with anti-tarnish or EVA inserts where metal parts are involved.
Compliance elements, specified at the quote stage
| Element | What we confirm |
|---|---|
| Substrate declaration | FSC-ready board and paper specs, with chain-of-custody documentation on request; PPWR-ready material positioning for EU shipments |
| Ink and food-contact adjacency | Soy-ink printing; for food-adjacent or skin-contact applications we specify low-migration ink options at quote |
| Batch and traceability printing | Lot, expiry and serial fields placed on the dieline before tooling; variable data confirmed on the pre-production sample |
| Structure for handling | Insert profiles cut to component dimensions; drop and compression checks on the pre-production sample |
| Inspection evidence | AQL inspection before shipment, with photo or video confirmation of the approved run |
Quality system
Every order runs through the same gate: artwork proof → pre-production sample on the real substrate → AQL inspection during production → pre-shipment inspection with photo or video confirmation. For qualification projects, this evidence pack is usually what the buyer’s regulatory or QA team needs on file.
Validation orders: the low-risk first step
Device packaging usually starts with a qualification run — 100 to 500 units to validate the pack on the real line before committing to volume. Digital print keeps the first run tooling-free, and the same dieline carries into offset once the specification is locked.
Frequently asked questions
- Can you provide material documentation? Yes — FSC-ready substrate documentation and chain-of-custody records are available on request.
- Can you print batch numbers and expiry dates? Yes — variable-data fields are placed on the dieline before tooling and confirmed on the pre-production sample.
- What is the MOQ for a validation run? From 100 pcs.
- How long does production take? Samples in days; bulk 2–3 weeks after sample approval.
- Can we inspect before shipment? Yes — AQL inspection with photo or video confirmation, or third-party inspection (SGS/BV) if you prefer.
Image note: two slots reserved for device-specific photography (kit interior with vial insert; batch-printed carton) — briefs ready when your photos are available.