Automate your labelling process to meet the most demanding traceability and regulatory standards — with zero room for error.
In medical devices and diagnostics, labels are more than information. They’re compliance lifelines. They protect patient safety, ensure product integrity, and meet stringent global regulations. Whether you’re shipping surgical tools, diagnostic kits, or implant components, your labels must be flawless, traceable, and verifiable — every single time.
As a production or quality leader in this field, you’re managing high-mix SKUs, cleanroom protocols, and evolving regulatory frameworks like UDI and EU MDR. Manual labelling just can’t keep up — and any mistake could trigger a product recall or audit failure.
That’s where Scan, Print & Apply delivers peace of mind. With SPA, your labels are always correct, compliant, and logged — without interrupting your production flow.
Here’s how SPA empowers manufacturers of medical devices and diagnostics to label with precision and confidence:
The Challenge:
Sterile products like surgical tools, implants, and diagnostic swabs must be labelled without compromising packaging or risking contamination. At the same time, traceability must be built into every pack.
How SPA Solves It:
✔ Applies high-resolution 2D codes and data on sterile pouches, trays, or cartons
✔ Uses medical-grade labels that adhere without affecting sterile barriers
✔ Operates inline with cleanroom-compatible applicators and minimal human touch
Implementation Example:
A surgical tool manufacturer uses SPA to apply traceable 2D DataMatrix codes to sterile-packed kits. Each label links to batch, expiry, and component data in the MES — without disrupting the cleanroom workflow.
The Challenge:
Compliance with UDI (Unique Device Identification) and MDR/IVDR requires precise labelling of each device, often down to the unit level — with serialization, expiry dates, and packaging hierarchies.
How SPA Solves It:
✔ Prints and applies UDI-compliant labels in real-time
✔ Supports GS1, HIBCC, and custom formats for different global markets
✔ Verifies label accuracy inline and logs every code for audit trails.
Implementation Example:
An orthopaedics supplier uses SPA to serialize every implant box and pallet with unique UDI-compliant labels. Each label is verified and linked to the digital device record in the company’s ERP.
The Challenge:
From COVID tests to blood samples, every vial or tray must be labelled fast, accurately, and with traceable data. Errors or mix-ups aren’t just costly — they’re dangerous.
How SPA Solves It:
✔ Applies small-format, high-resolution labels on micro-packaging
✔ Integrates with lab information systems (LIS) to pull sample-specific data
✔ Enables variable-data printing and auto-verification at speed.
Implementation Example:
A diagnostics lab uses SPA to apply test-specific barcodes and sample metadata to collection trays. Each label is matched to patient data from the LIS and verified before the tray enters processing.
The Challenge:
Shipping medical devices worldwide means complying with country-specific labelling regulations — often in multiple languages, with unique content formats.
How SPA Solves It:
✔ Switches label language and format instantly based on destination
✔ Pulls translation and compliance data from centralized systems
✔ Eliminates the need for multiple label inventories.
Implementation Example:
A device manufacturer distributes across Europe and Asia. SPA prints language-specific regulatory and use instructions in real time based on shipment data, ensuring full compliance without slowing down packing.
The Challenge:
Each label must be readable, permanent, and perfectly placed — especially for high-value products like implants and diagnostic machines where rework isn’t an option.
How SPA Solves It:
✔ Vision-guided systems ensure precise label placement and readability
✔ Labels are resistant to handling, sterilization, and transport
✔ Verification modules prevent unreadable or missing codes.
Implementation Example:
A cardiovascular device maker uses SPA to label implant packaging with high-durability UDI labels. Vision systems validate placement, and the data is logged into the manufacturer’s compliance system.
Here’s what happened when a global surgical device manufacturer faced mounting pressure to comply with UDI regulations across multiple markets:
⚠ Manual labelling introduced inconsistencies in UDI formatting and placement
⚠ Misaligned or missing labels caused inspection delays and failed shipments
⚠ Operators had to halt production frequently for label changeovers and checks
Scan, Print & Apply in Medical Devices & Diagnostics
