アジア太平洋 (日本語)
地域を選択

最高のウェブサイト体験のためには地域と言語を選択してください。

Barcode Better

TEKLYNXでは、お客様が購入するのは単にバーコードソフトウェアだけではないと考えています。それは、お客様の企業経営に寄与する統合化技術ソリューションです。

Blog

Why TEKLYNX is the Best Labeling Software for Medical Devices

ニック・レヒト

Why TEKLYNX is the Best Labeling Software for Medical Devices

BY: NICK RECHT / DATE: 09/06/2020 / TOPICS: 医療機器, 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.

 

REQUEST A FREE CONSULT

 

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) 

 

UDI LabelThe 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
 
Record Generation
 
Audit Trails
 
Operational Controls
 
Security Controls
 
Digital Signatures
 
Training

 

 

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:

 

UDI issuing agencies for EU MDR are:

 

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 achieved labeling efficiency with TEKLYNX CENTRAL CFRMicroVention 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.

 

 

Looking for the best labeling software for your medical devices? We’re here to help!

 

GET IN TOUCH

 

TEKLYNX helps you find a complete labeling software solution to meet every one of your needs.

 

About Nick

 

Nick Recht is the Sales Manager for the Americas region at TEKLYNX RFID and barcode label solution provider. He leverages his passion for using technology to add value to businesses and his 15 years of AIDC experience to help organizations of all sizes barcode better. When he is not working, he is driving one of his daughters to a practice of some sort or doing a project around the house.

 

Subscribe to The Human Readable blog

 

SUBSCRIBE

 

Share this post with your network:

Related Blog Posts

Why Commercial Off The Shelf Labeling Software Solutions are the Right Fit

BY: JENNA WAGNER / DATE: 20/02/2020 / TOPICS: LABEL DESIGN, ENTERPRISE LABEL MANAGEMENT

 

At first glance, the custom option to almost anything sounds like the ideal solution. It's tailored to your needs exactly - what more could you ask for. If you're looking to save money and reduce unnecessary headaches, custom designed solutions might not be the right fit for you.

READ MORE

How to Eliminate Waste in Label Printing with Lean Labeling Principles

BY: TRAVIS WAYNE / DATE: 28/01/2020 / TOPICS: LABEL DESIGN

 

When it comes to your barcode labeling software solution, implementing lean labeling and continuous improvement principles to your labeling environment reduces waste in label printing and saves you money.  

READ MORE

Need for Speed: Tips to Boost Label Print Speeds

BY: TRAVIS WAYNE / DATE: 29/01/2019 / TOPICS: ENTERPRISE LABEL MANAGEMENT, PRINT AUTOMATION, LABEL DESIGN

 

Does your company have a labeling goal of printing faster? Most companies do since faster print speeds ultimately create efficiency. To help your company begin achieving its labeling goal, TEKLYNX has developed three labeling best practices focused on streamlining the printing process to create faster print speeds. Let's start with the best practice that focuses on the core way print speeds are affected: communication.

Read More

What do you think? Leave us a comment.

Comments will be reviewed and are subject to TEKLYNX’ comment policy. Your email address will not be published publicly.

 

必須フィールド
必須フィールド 無効
必須フィールド
There was an error adding your comment. Please try again.
必須フィールド

Add Comment
You have successfully submitted a comment. Your comment will be published after review. You will be notified by email when your comment is published. If you have any questions in the meantime, please contact TEKLYNX in your region.