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​​Track and Trace Solutions for Medical Devices​

Accurately tracking medical devices and equipment is critical for meeting global regulations and ensuring patient safety. Code reading challenges like low contrast, shrink-wrap distortion, or curved surfaces demand advanced technology capable of reliably interpreting both barcodes and alphanumeric characters. High-performance barcode scanning and OCR solutions from Cognex deliver fast, accurate identification across every stage of production, packaging, and delivery.

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​​Comply with global safety mandates using AI-powered machine vision​

​​​​In the highly regulated world of healthcare, tracking medical devices from manufacturing to hospitals and patient care is critical. The process involves assigning and reading unique device identifiers (UDIs) on every device, case, and pallet using barcodes or alphanumeric codes.  

​UDIs combine a device model identifier and production data, like lots and serial numbers, that enable medical device companies to track and trace components throughout the supply chain. Required by the U.S. Food and Drug Administration (FDA) and the European Union’s Medical Device Regulation (EU MDR), UDIs improve post-market surveillance, reduces errors, and enhances supply chain visibility.

​Effective traceability also supports compliance with FDA 21 CFR Part 11, which governs the use of electronic records and signatures in FDA-regulated industries. It ensures that digital documentation of device history is secure, validated, and audit-ready.

​By implementing compliant vision and code-reading systems, manufacturers can reduce errors, streamline workflows, and build trust - ensuring that every device is accounted for, from production to patient care.

Barcodes for Medical Devices White Paper | English

Download Barcodes for Medical Devices: What You Need to Know About UDI Regulations White Paper

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Track, trace, trust: Accurate barcode reads enable total visibility

Barcodes and alphanumeric codes on medical devices aren’t always printed in ideal conditions. They can be low contrast, blurred, marked on shiny or white surfaces, recessed into parts, distorted under shrink-wrap, or placed on multiple sides of a package – sometimes at extreme angles or extended distances. These challenges apply to both direct part marks (DPMs) and label-based codes.

​Tough-to-read or poorly marked codes can slow production, delay shipments, increase scrap and reprint costs, complicate audits, and even pose patient safety risks. Traditional scanning systems often struggle with the variability in code size, type, and placement - especially when lighting conditions or surface materials make readability a challenge. 

​From manufacturing lines to hospitals, advanced barcode scanning and OCR technology guarantees critical data is captured correctly – supporting patient safety, regulatory compliance, and operational efficiency. The right lighting for these machine vision systems maximizes contrast on key features and minimizes it elsewhere, helping scanners overcome glare, shadows, and surface inconsistencies.

​Whether you’re scanning inline during production or conducting spot checks, high-performance systems provide the precision and adaptability needed to ensure codes are readable wherever they travel around the world.

Healthcare IS8000 Pacemaker DPM and UDI code

​A Cognex vision system reads DPM and UDI codes at the same time.​


​​Full traceability, faster tracking – powered by Cogn​ex 

Cognex AI-powered vision systems and DataMan barcode readers use advanced imaging and optics to increase read rates. For high-speed production lines or complex part geometries, these integrated solutions streamline operations by reading complex, deformed, and skewed codes in challenging conditions:

  • ​Advanced OCR capabilities like pretrained font libraries provide precise character recognition, even on curved, reflective, or irregular surfaces, by using sophisticated algorithms and adaptable lighting solutions that enhance image clarity.  
  • ​Leveraging powerful imaging technology and AI-powered tools, DataMan barcode scanners ensure exceptional performance and reliability.
  • ​Large depth of field and wide field of view allow multiple codes to be scanned simultaneously on aggregated boxes or pallets.

Fixed-mount and handheld options provide flexibility to scan medical devices of all shapes and sizes, essential for efficient identification and recall processes. Designed for easy integration and fast deployments, these solutions fit effortlessly into any production environment. Plus, global access to Cognex experts and a robust suite of self-service resources are available whenever you need them. Scan smarter, stay compliant, and protect quality and patient safety when it matters most. 

DataMan 475V verifies DPM codes on medical instruments

​Barcode verifiers grade codes to ensure they meet ISO standards.


​Barcode verification supports reliable traceability and compliance 

​​Cognex barcode verifiers give manufacturers greater control by ensuring every 1D and 2D code meets ISO and industry-specific standards. These systems automatically grade codes based on contrast, modulation, and other critical parameters, guaranteeing reliable readability throughout the supply chain.

​Cognex in-line and offline barcode verifiers can grade up to 20 codes per second, enabling high-speed, 100% verification. This prevents product waste, reduces costly errors and chargebacks, and ensures consistent code quality. 

​Operators gain immediate feedback and intuitive visual diagnostics, allowing them to quickly identify and correct printing or process issues. Every verified code is logged with detailed reports to support traceability, statistical process control, and regulatory compliance. By meeting standards like UDI and ISO/IEC 15415, Cognex barcode verification helps safeguard product quality, which is vital in medical device and equipment manufacturing.​ 

Introduction To Barcode Verification White Paper | English

Introduction to Barcode Verification Guide

Learn how barcode verification improves traceability and compliance by ensuring code quality and accuracy.

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