“BarTender’s optimized labeling operations enable a medical device manufacturer’s centralized, standardized, compliant printing for SGTIN-96 RFID tags.”
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Medical Devices
Improve device traceability and patient safety
Accurate device identification from production to patient
In medical device manufacturing, labels are more than product identifiers. They’re a regulated element of the product itself. BarTender combines Labeling and Track & Trace to help you maintain accurate device identification, support UDI compliance, and improve traceability across production, distribution, and field inventory—so you can optimize operations while reducing risk.
Trusted by medical device manufacturers worldwide
What is integrated labeling and tracking for medical devices
What is integrated labeling and tracking for medical devices
Integrated labeling and tracking connects compliant label creation with the systems that receive, track, and report on every medical device, implant, and component throughout its lifecycle. Device labels carry the UDI identifiers, lot and serial numbers, expiration dates, barcodes, and RFID data that link to regulatory databases such as GUDID and EUDAMED. By bringing labeling and tracking together, BarTender helps manufacturers maintain accurate records, respond more quickly to recalls and audits, and improve visibility across production, distribution, and field inventory.
UDI and MDR compliance built into every label
BarTender helps medical device manufacturers create UDI- and MDR-compliant labels with lot numbers, expiration dates, and correctly formatted GS1 or HIBCC codes populated automatically from master data sources. Intelligent Templates help ensure label data remains aligned with FDA and EU requirements, while centralized template management makes it easier to apply regulatory updates instantly across products, facilities, and printer networks.
Gain visibility into field and manufacturer-owned inventory
BarTender Track & Trace helps medical device companies manage high-value, manufacturer-owned inventory spread across hospitals, surgical centers, sales rep trunk stock, and warehouses, often with limited visibility. Devices are scanned at receiving, assigned to zones, and tracked through every movement, creating item-level visibility. With RFID support, cycle counts can be completed in minutes at 95%+ accuracy. During recalls or audits, teams can quickly and precisely identify and locate affected devices.
Automated reconciliation with scan-based receiving
BarTender Track & Trace replaces manual receiving with scan-based verification against ASNs. Operators scan barcodes or RFID tags, and the system validates each item in real time against expected shipments. Quantities are confirmed, shortages and overages are flagged immediately, and lot and serial data flow automatically into your ERP. For manufacturers coordinating with contract manufacturers and outside vendors, this helps reduce keying errors and reconciliation delays that can introduce inaccurate data into quality systems.
Success Story
Zimmer Biomet: 99.99% uptime across all global medical device labeling operations
Learn how Zimmer Biomet standardized global medical device labeling by selecting BarTender-powered ROBAR, replacing fragmented legacy systems after years of acquisitions. The result was highly resilient, compliant enterprise labeling with 99.99% uptime, three‑second global print response times, and support for 125,000+ labels.
Scale labeling and traceability across products, facilities, and markets
Scale labeling and traceability across products, facilities, and markets
Manage mass label updates across products and facilities
BarTender Intelligent Templates help medical device manufacturers apply labeling updates instantly across thousands of SKUs and multiple facilities from a single source. Changes to UDI formatting requirements, updated MDR Annex I content, and market-specific language can be managed centrally and consistently, without manual template-by-template revisions.
Maintain audit-ready records for compliance and inspections
BarTender provides complete audit trails, showing who accessed a label, what edits were made, and where and when it was printed. Electronic signatures, role-based access controls, and tamper-evident logs support FDA 21 CFR Part 11 and EU MDR requirements. Track & Trace adds full item movement history and one-click export for audits and regulatory inspections.
Support global and multilingual labeling from one platform
BarTender helps medical device manufacturers manage destination-specific labeling requirements across markets, languages, and regulatory frameworks—all from a single platform. Intelligent Templates can evaluate existing label content and automatically generate the supplemental labels needed based on a product’s destination, helping reduce manual language management and reducing compliance risk across markets.
Better together
Keep production moving—with full visibility, built in
When labeling and tracking are disconnected, errors multiply and visibility disappears. BarTender brings them together—so every label becomes the start of a complete, traceable record.
- One source of truth
Label data flows directly into tracking—no duplicate entry or mismatched records - Instant traceability
Track items from creation through production, storage, and shipment - Faster audits and recalls
Access a complete history of every item, label, and movement - Simplified operations
One platform, one system, one partner for labeling and tracking
Modernize your medical device operations with BarTender
Simplify your labeling. Gain real-time visibility. Improve accuracy across every stage of production.
Labeling and tracking for medical devices FAQs
Labeling and tracking for medical devices FAQs
Yes. BarTender supports FDA UDI labeling requirements, autoformatting GS1 and HIBCC codes, supporting 2D Data Matrix and 95+ other symbologies, and integrating UDI Intelligent Templates connected to master data. Serialization is managed across your entire printer network.
Yes. BarTender helps medical device manufacturers maintain alignment between label data and EU MDR requirements, including EUDAMED registration records. Version control and audit trails support MDR documentation requirements, and mass updates for regulatory changes can be made across all facilities instantly.
BarTender Labeling creates compliant medical device labels with UDI identifiers, lot and serial numbers, barcodes, and RFID data. Track & Trace scans, tracks, and reports on every device across your supply chain, including receiving reconciliation, zone-level location, movement history, and recall scoping. Together, they help manufacturers maintain device traceability from label creation through distribution and field inventory.
Yes. Track & Trace maintains a serialized chain-of-custody history of receiving, movement, and inventory events for each device. When a recall or field safety corrective action is issued, manufacturers can identify affected serial numbers and current device locations quickly, helping limit the scope of actions and investigations.
Yes. BarTender supports 21 CFR Part 11 requirements with electronic signatures, role-based access controls, password-protected authentication, and tamper-evident audit trails that help support data integrity and non-repudiation requirements.
Yes. BarTender supports destination-based labeling by evaluating existing label content and automatically generating supplemental labels when additional languages or market-specific information are required. This helps medical device manufacturers manage global distribution across multiple regulatory and language environments from a single platform.
BarTender is available as on-premises software, cloud-based software, or a hybrid deployment. Medical device manufacturers often use on-premises deployments for strict validation and data residency requirements, while BarTender Cloud supports multi-site operations and supplier enablement. Hybrid deployments combine centralized control with flexible cloud access across manufacturing and distribution operations.
Success stories
More medical device success stories
More medical device success stories
