3 Ways Medical Device Companies Use Label Security & Traceability Software

3 Ways Medical Device Companies Use Label Security & Traceability Software

BY: NICK RECHT / DATE: 09/10/2025 / TOPICS: MEDISCH APPARAAT, ENTERPRISE LABEL MANAGEMENT, LABEL TRACEABILITY, REGULATORY COMPLIANCE

The medical device sector is one of the most regulated industries, and for a good reason: to keep people safe. When it comes to labeling medical devices or parts, label security and traceability in your labeling software need to be implemented to ensure patient safety.

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In this blog, we’ll go over the important regulations in the medical device industry and how three different medical device companies implemented label security & traceability software into their labeling process.

Labeling regulations for medical device

With the medical device sector being part of one of the most regulated industries, it’s important for companies to be aware of the different regulations in order to remain compliant.

Unique Device Identification (UDI)

The Food and Drug Administration (FDA) requires that all medical devices distributed in the United States (US) must be labeled with a Unique Device Identifier (UDI). A UDI is a numeric or alphanumeric code that uniquely identifies medical devices within the supply chain. This requirement applies to all implantable and life-supporting or life-sustaining medical devices. Proper UDI labeling helps reduce medical errors, streamlines data system integration, and enables faster problem resolution. 

Download a free UDI label sample

FDA 21 CFR Part 11

FDA 21 CFR Part 11 applies to the research, manufacturing, and distribution of medical products. It was established to protect public health, ensure the integrity of electronic medical records, and enable organizations to reduce costs by replacing paper records with electronic systems. Some key aspects include:

• Audit trails: Maintain an accurate and detailed record of all changes, comments, revisions, and print history of every label through an audit trail. 
• Electronic records: Ensure records are accurate, complete, and stored in a secure place for easy access.
• Validation: Validate systems to confirm accuracy, reliability, and consistent performance. Accelerate the validation of your labeling system with IQ, OQ, PQ documentation. 
• Security controls: Limit access to the labeling system and track activity for each file to identify who made edits, supporting compliance in regulated environments.

TEKLYNX CENTRAL enterprise label management solution is designed to help organizations comply with FDA 21 CFR Part 11.

European Union Medical Device Regulation (EU MDR)

EU MDR is designed to protect public health and patient safety across Europe while improving the quality and transparency of medical devices in the healthcare supply chain. It standardizes label design, approval, and tracking to ensure consistency and compliance.

All medical device labels—except for custom-made devices and those used in performance studies or investigations—must include a UDI, PI (Product Identifier), and HRI (Human Readable Information). Medical device manufacturers and distributors throughout Europe are required to comply with EU MDR labeling standards. Learn more about EU MDR.

Download a free EU MDR label sample

Now that we’ve reviewed the key regulations organizations in the medical device industry must comply with, we will show you some real-world use cases.

Case 1: Creating an automated label approval process 

A worldwide distributor of medical and dental supplies experienced inefficiencies in their label approval process that led to wasted time and major delays. Originally, their label approval processed looked like this: 

1. Someone designs a label and prints out a sample 
2. The label designer delivers the label print out to the Quality Assurance (QA) department 
3. The label approver in the QA department makes edits or changes onto the label, and walks it back to the label designer 
4. The label designer goes to their computer to make requested changes to the label 
5. Once changes are made, the label designer brings a new printed version to the label approver 
6. The label approver approves the label and signs it 
7. Finally, the label approver files the label in a physical folder 

This manual label approval process is long and frustrating, especially when multiple changes or reviewers are involved. Not only is this manual approval process a waste of time, but maintaining permanent records of physical labels is inefficient, takes up unnecessary space, and is not secure. Manual edits also increase room for errors.

With the help of TEKLYNX, the dental supply company was able to solve their inefficient labeling process by implementing LABEL ARCHIVE, label security & traceability software. They cut down their label approval process time by over 75% and instead of having to manually deliver printed label copies for approval, they now have an entire paperless label approval process that is done by a simple click of a button.  

Case 2: Achieving compliance with medical device labeling regulations

As a leading designer and developer of upper and lower spinal orthotics in the healthcare industry, Aspen Medical Products, sought a solution that could improve its ability to meet the vast and ever-changing medical device compliance standards such as the FDA’s standard 21 CFR Part 11 which requires approvals via electronic signature.

With TEKLYNX label security & traceability software for medical devices, Aspen Medical Products improved their ability to comply with medical device manufacturer labeling regulations. TEKLYNX supplemented Aspen Medical Products with access to a label approval module that enables electronic approvals while ensuring full traceability in accordance with FDA CFR Part 11.

Case 3: Implementing label security & traceability software within the medical device industry

MicroVention, a world-renowned developer and manufacturer of innovative neuroendovascular technologies, needed to support a global and secure multi-user labeling environment that had over 50 different employees in four different facilities that needed access to print labels. While operating in locations such as the US, Costa Rica, and China, MicroVention’s growing global presence required them to be particularly mindful of potential security and accessibility issues related to the company’s data center.

By enabling a label design and approval process with user controls, MicroVention gained confidence in the security of their labels and entire labeling process. User controls and permissions are used to separate users based on their role in the labeling process:

• The label designer has access to the label design software where they can edit and design labels. Once the label is drafted, the label designer can submit the label into the approval workflow directly within the software.  
• The label approver finds labels that need to be verified in the approval workflow and approves the label or requests changes within the software. 
• Once a label is approved, the print user can access the labels but does not have the ability to edit the label or label template. This ensures only the approved label is printed for maximum security.  

TEKLYNX assisted MicroVention by providing the desired level of data center security throughout their global networks with label security and traceability software. Not only are user privileges controlled with customizable groups so only authorized individuals can use the system, but the security and traceability software also records audit trails throughout the lifecycle of the label, making MicroVention audit ready.

Watch the full case study in action.

Label security & traceability software for medical device by TEKLYNX 

LABEL ARCHIVE label security & traceability software, offers secure approval and label storage for your entire organization. Specifically designed to integrate with CODESOFT barcode label design software, LABEL ARCHIVE features follow your label from initial design to approval to final distribution and everything in between, giving your business the ability to comply with any relevant industry standard. LABEL ARCHIVE eliminates manual processes surrounding label design approval and helps minimize user error by only printing approved labels.

• Compliance: 21 CFR Part 11 compliance requires security, traceability, and version control. LABEL ARCHIVE provides the functionality you need to meet FDA and other industry standards. 
• Approval: Choose labels ready for production & deny those that aren’t. Eliminate errors with LABEL ARCHIVE email notification capabilities. When a label is created & submitted, get instant alerts. 
• Security: LABEL ARCHIVE allows administrators to easily create and maintain user groups and establish permissions to control access. 
• Traceability: The system captures and reports on changes, comments, revisions, and print history for every label in your system. 

In highly regulated spaces such as the medical device industry, a secure label process that offers maximum traceability is a must. If you are looking to add more security and traceability to your medical labeling environment, we’re here to help!

  Get in touch with TEKLYNX and let us help you find a complete labeling software solution to meet your every requirement.

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