Why TEKLYNX is the Best Labeling Software for Medical Devices

Why TEKLYNX is the Best Labeling Software for Medical Devices

BY: NICK RECHT / DATE: 09/06/2020 / TOPICS: MEDISCH APPARAAT, ENTERPRISE LABEL MANAGEMENT, LABEL TRACEABILITY, REGULATORY COMPLIANCE

The medical device industry is one of the most highly regulated industries out there. It’s crucial when choosing the best labeling software for medical devices that your solution has the necessary features to keep your business running efficiently. Your labeling software solution should help your company comply with global medical device labeling regulations.

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Here are two US Food and Drug Administration (FDA) labeling regulations the medical device industry faces that are critical for any company distributing medical devices in the US to comply with: 

FDA Unique Device Identification (UDI) 

The FDA requires that all medical devices distributed in the United States are labeled with a Unique Device Identifier (UDI). A UDI is comprised of a unique numeric or alphanumeric code that is used to mark and identify medical devices within the supply chain. To ensure uniqueness of UDIs, the FDA has accredited three issuing agencies: GS1, HIBCC, and ICCBBA. Using a UDI on every model and version of a medical device means more rapid identification of medical devices with adverse events, more rapid development of solutions to reported problems, and more rapid and efficient resolutions of device recalls.

Becoming UDI compliant includes three components:

1. Include Unique Device Identifier in all applicable systems and procedures
2. Accurate labeling of all devices and packaging
3. Load the Device Identifier (DI) with all the required information into the Global Unique Device Identification Database (GUDID)

When you have the right labeling software for medical devices, becoming compliant and implementing UDI is easy. TEKLYNX software has built-in HIBC and GS1 barcode generator wizards that make getting (and staying) compliant easy. 

Your labeling software should be able to support database connections and variable data to make managing your UDI labels simpler, more efficient, and less error prone. Your software should also include full barcode and RFID support. With robust database connection capabilities and RFID support, CODESOFT is a powerful label design application solution for UDI label design and management.

Want to learn more about UDI labeling for medical devices? Check out our eBook, Life Sciences Labeling & Compliance.

FDA 21 CFR Part 11

Established to protect the public health and to ensure accuracy of electronic medical records, FDA 21 CFR Part 11 applies to the research, manufacturing, and distribution of medical products. FDA 21 CFR Part 11 enables organizations to reduce costs by using electronic records in lieu of paper.

There are 7 elements to FDA 21 CFR Part 11:

Validation

• Validation of systems to ensure accuracy, reliability, and consistent intended performance. Firmly define how all elements of your system are supposed to work – this gives you reassurance on the security of the data and audit logs. Learn how TEKLYNX is helping companies accelerate the validation of their labeling systems. 

Record Generation

• Your system must have an indexing and search functionality so records can be found easily and quickly.

Audit Trails

• The best labeling software for medical devices should ensure the development of all your processes are well documented and traceable. The audit trail should be generated automatically and not be modifiable.

Operational Controls

• Ensure documents are reviewed by specified individuals and that requirements are being met before they are signed off on by implementing quality controls.

Security Controls

• Access to your system should be highly controlled and not accessible to a wide range of users. When security is high and there are few users, tracking each file and identifying those who have altered it will be easy.

Digital Signatures

• Part 11 has extremely specific requirements mapped out for digital signatures. One differentiating factor in Part 11 in terms of electronic signatures is the recognized Certification Authority that acts as a notary to verify the identity of a signer. These digital signatures are used so businesses can be more streamlined and efficient.

Training

• To be a proper and compliant system, all users must have the necessary training to perform tasks within a certified environment.

In such a highly regulated environment, it’s crucial to have a barcode labeling software solution that keeps you compliant and running efficiently. TEKLYNX CENTRAL CFR is an enterprise label management solution designed specifically to help organizations comply with FDA 21 CFR Part 11. It enables users to create complex barcodes such as the 2D DataMatrix barcode, Health Industry Bar Code (HIBC), GS1 Databar, and more. To ensure your environment is secure and compliant, establish user permissions and apply electronic signatures to your labels throughout their entire lifecycle.

To learn more about TEKLYNX CENTRAL CFR, request a free demo.

European Union Medical Device Regulation (EU MDR)

The EU MDR was designed to ensure public health and patient safety across Europe and to increase quality and transparency of medical devices in the healthcare supply chain through label design, label approval, and label tracking standardization. Within the healthcare industry, many organizations who have medical devices that are implantable, life-supporting, or life-sustaining, must also bear a Unique Device Identifier (UDI) on its labels.

This includes:

• Device Identifier (DI) which is a unique numeric or alphanumeric value associated with a specific version and model of a medical device.
• Production Identifiers (PI) which includes information such as a lot number, serial number, manufacture date, and expiration date. If they are on the label in easily readable plain-text, they must also be in the Automatic Identification and Data Capture (AIDC) format.
• Human Readable Information (HRI) which is a representation of data that can be naturally read by humans.

UDI issuing agencies for EU MDR are:

• GS1
• Healthy Industry Business Communications Council (HIBCC)
• International Council for Commonality in Blood Banking Automation (ICCBBA)
• Informationsstelle für Arzneispezialitäten (IFA) GmbH

All medical device manufacturers doing business in Europe must comply with EU MDR guidelines by May 26, 2021.

Medical Device Labeling Software Case Study

MicroVention is a leading medical device company headquartered in California. A world-renowned developer, manufacturer and marketer of innovative neuroendovascular technologies, MicroVention operates facilities in California, Costa Rica, and China. After experiencing rapid growth and expanding distribution into international markets, MicroVention realized they needed a more efficient and controlled labeling solution.

MicroVention collaborated with the TEKLYNX Enterprise Team to determine that a browser-based, integrated enterprise label management system, TEKLYNX CENTRAL CFR, would be a scalable and efficient solution for managing its multiple facilities and providing bandwidth for future growth. After implementation took place, MicroVention streamlined its entire labeling process, resulting in a 50% improvement in production efficiency. They also saw major improvements in their ability to comply with UDI regulations as well as reduced risk of human error by using database-driven templates.

Read the MicroVention case study.

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