UDI Marking and Quality Inspection
Maintain UDI compliance with machine vision, deep learning, and barcode verification
The United States Food and Drug Administration (FDA) Unique Device Identifier (UDI) mandate and the European Commission Medical Device and In Vitro Diagnostic Regulations (MDR/IVDR) require the use of UDI marks to trace medical devices. The mark must be readable and decipherable throughout the device lifecycle to maintain compliance. Properly marking medical devices provides a faster method to identify faulty, recalled, expired, or counterfeit products. The UDI barcode should list the medical device information, lot number, serial number, manufacture and expiration dates in human and machine readable form.
Barcodes can be applied using a variety of methods, with the most common being thermal transfer labels or direct part marking (DPM). Barcode printing errors and poor label quality require manual intervention, slowing down production and presenting challenges to partners along the supply chain. Quality inspections must verify that the codes are present and printed correctly to ensure traceability and more easily manage recalls. Optical character recognition (OCR) is used for reliable process control, helping manufacturers meet labeling requirements and ensure patient safety.
Cognex vision systems with OCR technology detects the presence or absence of codes and verifies that its chain of numbers and letters is correct. For challenging OCR, including laser marked or DPM text, Cognex AI-based solutions ensure codes are accurately read and verified. AI-powered OCR tools decipher deformed, skewed, and poorly etched characters using optical character verification (OCV). The pretrained, omni-font library identifies most text without additional programming or font training.
Cognex inline and handheld barcode verifiers grade the quality of label-based and DPM codes to ensure they meet quality thresholds. Verifiers require calibration and use specified lighting to meet quality standards. An overall grade is assigned based on several quality parameters and a report is generated to certify code quality. By monitoring verification results, code issues can be identified when quality starts to decline so corrective action can be taken right away.