Medical device labeling
Medical devices are held to a high standard, and are regulated by stringent governmental and independent standards. Medical device labeling, likewise, is a strictly regulated process.
Resource Label Group customizes label design, construction and manufacturing process solutions for medical device labels that abide by all industry regulations. We follow meticulous quality management processes to ensure each label we produce is made to your exact FDA-approved specifications using current good manufacturing practices (cGMPs).
We know how important traceability and documentation is in the medical industry. Using our robust ERP system, we are able to collect all data you require, offering you complete traceability into all raw materials we use and each label we produce.
Customizing a label manufacturing solution for your medical device
No two medical devices are the same. That’s why you need to choose a medical device labeling manufacturer that is able to configure their manufacturing process to your specific requirements, meeting your exact specifications every time for every label.
Resource Label Group has a state-of-the-art facility equipped with the latest printing, manufacturing and inventory management features. We’ll work with you to determine the label construction and manufacturing process that best works for your device, while meeting all industry regulations for label manufacturing.
It’s important to first work with regulatory agencies to determine what information and features need to be included on your label. With your FDA-approved design in hand, we’ll begin designing a label construction that meets those specifications. During the product and process development stage, we’ll test and verify possible solutions that meet your security, performance and regulatory requirements.
Using our full suite of label printing and manufacturing capabilities, we are able to design and execute a label construction for even the most complex medical devices. Here are a few of the features we can incorporate into your medical device label:
- Near field communication (NFC) tags for interactive and tracking capabilities
- Extended content labels (ECLs)
- Piggyback labels
- Security and tamper-proof features
- Warning areas
- Radio-frequency identification (RFID) labels for tracking products
- Micro text, holographic images and specialty foils for anti-counterfeit protection
- QR codes to provide more information online
- Transparent windows
Our cross-functional innovation team has the expertise to design a medical device label that turns the most complex FDA specifications from theory to reality. Through initial testing, feasibility studies and reviewing materials for regulatory compliance we are not only able to make recommendations, but validate them as well.
Quality management and manufacturing standards we follow
With medical device labeling, it’s not only the design that counts. The manufacturing process used to create the end product is just as important. Medical device label manufacturers must follow stringent quality management guidelines to ensure each label is made to its exact specifications.
From label construction to security and traceability safeguards, we can customize a label manufacturing process that gives you all the documentation and data you need to meet regulatory compliance. Through our ERP system, we are able to provide you complete traceability and chain-of-custody documentation for every material from the moment it enters our secure facility as a raw material to the moment it leaves as a label, individually marked with a control number.
Here are the quality management and manufacturing standards we follow:
- Current Good Manufacturing Principles (cGMPs)
cGMPs were developed by the FDA to ensure the replicability of manufacturing processes. Medical device label manufacturers are required by law to abide by cGMPs in order to make sure each label they produce aligns with its FDA-approved specifications, with the ultimate goal of providing safe and effective end products to patients.
- International Standards Organization (ISO) 13485
ISO 13485 is another standard regulating medical device label manufacturing and, specifically, the quality management standards they have in place. Resource Label Group is ISO-13485-certified, meaning our facility and quality management processes have been independently audited and verified.
Through adherence to strict quality control and security guidelines, we are able to produce high-quality medical device labels every time. We take great care during the manufacturing process to prevent mistakes, ensure quality and deliver an effective, easy-to-use product.
Labels communicate important information — what a device should be used for, the risks associated with using it and more. From label construction to feasibility testing to manufacturing, we are able to assist you with the creation of a medical device label that not only meets regulatory requirements, but delivers quality to the end user — patients.
For innovative labeling solutions for medical devices that take regulation and quality into account, work with Resource Label Group. Request a free consultation to begin developing a medical device labeling solution today.