A mid-sized surgical device manufacturer specializing in implantable medical devices faced growing challenges with its labeling process. As demand for its products increased, so did the complexity of labeling requirements, particularly with global expansion and evolving regulatory standards such as FDA UDI, EU MDR, and ISO 13485 compliance.
Challenge
The company relied on pre-printed labels sourced in bulk from an external vendor. Any last-minute design changes (whether due to updated regulatory guidance, product iterations, or language localization) required halting production, discarding obsolete labels, and waiting days or even weeks for new ones to arrive. This created significant labeling bottlenecks on the production floor and introduced the risk of mislabeling or misbranding, both of which carry steep civil and criminal penalties under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Compounding the problem, compliance audits were becoming more frequent and rigorous. Inspectors scrutinized label traceability, print quality, and version control. Manual reconciliation of batch numbers and expiration dates increased anxiety across the quality and regulatory teams.
Solution
The manufacturer implemented an on-demand labeling solution using Afinia’s industrial-grade color label printers. This shift enabled the team to print serialized, high-resolution labels in-house and on demand. This eliminated dependency on external suppliers and the need to stockpile labels for every SKU.
Integration with the company’s ERP system ensured that label templates pulled the correct product information, lot numbers, and unique device identifiers (UDIs) automatically. Quality assurance personnel could now review and approve labels digitally before printing, reducing errors and speeding up change implementation.
Results
The transition to on-demand printing yielded immediate benefits:
- Audit Readiness: The ability to generate traceable labels with full version control improved confidence during inspections. Auditors commended the transparency and control built into the new labeling workflow.
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Time-to-Market: Label revisions — once a multi-day process — could now be executed and validated within hours. This agility proved especially valuable during a recent product line expansion.
- Cost and Waste Reduction: Eliminating pre-printed label inventory reduced material waste from obsolescence and lowered associated procurement costs by over 30%.
By modernizing its labeling operations, the company turned a longstanding compliance risk into a competitive advantage — enabling it to scale more efficiently, respond to regulatory changes with agility, and ensure consistent label quality across its implantable pulse generator portfolio.
