562-207-1680 info@protechdesign.com

MEDICAL DEVICE LABELING

 

Label picture 1PRO-TECH offers full-service label design and printing through our in-house graphics department. Medical Device Labeling is one of the company’s areas of expertise. PRO-TECH understands the balance necessary to maintain accuracy and security alongside high production volumes.

We know how important it is to meet stringent ISO and FDA labeling requirements and we have the experience, flexibility, and technology to accommodate short-run engineering builds as well as full-size production runs.

All label content can be controlled and verified from printer to shipping carton though our proprietary Label Control Software (LCS). As a result, labeling for serialized products is subject to rigorous checks including serial number controls that verify to avoid duplication across builds.

We are committed to continued progress is using cutting-edge technologies. Our investment in systems ranging from automated Label Counting Machines to Machine Vision systems allows us to increase capacity, preserve quality, and provide you with confidence in our labeling capabilities.

 

 

Our capabilities include:Label picture 2

  • Label Development and Proofing
  • Stock materials validated to ISO Standards
  • Barcode Setup and Verification
  • GS1, HIBC, UDI Compliant
  • 2D Barcode Capable
  • Digital On-Demand Printing
  • Laser and LED-Based Systems
  • Inkjet-Based Systems
  • Thermal and Thermal Transfer Based Systems
  • Custom Sized and Shaped Labels using Label Finishers and Laminators
  • Direct Print Tyvek Capabilities for Preformed Pouches and Lids

For more information on our medical device labeling capabilities, please Contact Us today.

CUSTOMER CASE STUDIES

Labeling

100% Traceability & Accuracy

One of the biggest concerns we hear from potential customers when looking for a contract manufacturer, is the reliability of their quality control systems. In particular, they are concerned with the tracking and accuracy of labeling. They know that error-free label production is critically important. If the wrong labels are used, the results can be disastrous. At PRO-TECH, we’ve addressed this concern by developing a customized label tracking system to ensure ultimate traceability and accuracy to meet the exacting standards of the FDA and our medical device customers.

SITUATION

Recently, a new customer approached us about assembling and packaging a complex series of products that had multiple sub-components for each product. Each sub-component needed to be labeled and monitored to ensure accuracy from the reception of the initial components all the way to final shipping of the fully assembled product.

There was no margin for error and key milestone checks needed to be systematically automated. This potential client would not become a full-fledged customer without strong assurances that PRO-TECH could handle their complex situation.

ACTION

Anticipating the needs of current and future customers, PRO-TECH had already invested in the development of a customized label tracking system to handle the complexity of just such a project.

PRO-TECH’s proprietary software uses barcode scanners and vision systems to 100% digitally verify label content at each stage in the assembly process. We also offered the customer access to a dedicated customer portal so they could track production throughout the assembly process, giving them additional piece of mind.

RESULTS

The potential customer was so impressed with the capabilities of the system and the personalized experience from the team, that they placed an order right away.

Now, the launch is on-target and all label tracking has been 100% traceable and accurate.

The customer is already thinking of awarding a second product line to PRO-TECH.