QC Automation of
Labeling / Technical Documents

In the medical device industry, a label is more than just a sticker – it is a critical component of the product. An incorrect expiry date, a missing UDI (Unique Device Identifier), or a mismatched symbol can lead to costly recalls, regulatory fines, and, most importantly, patient safety risks.

Our Automated Label QC Solution leverages AI and statistical methods to eliminate manual, error-prone inspections into a high-precision, automated workflow.

Schedule Demo

The Challenge: Precision at Scale

Medical device labeling must adhere to stringent global standards (such as FDA 21 CFR Part 801 and EU MDR).

Manually verifying every field against regulations and product technical documents is slow and susceptible to human fatigue.

Our solution automates this by extracting, verifying, and validating every data point in seconds.

Core Capabilities

Intelligent Field Extraction

Using advanced Optical Character Recognition (OCR) and Natural Language Processing (NLP), the system
scans labels to identify and extract critical data fields, including:

UDI / GTIN

Ensuring the barcode matches the human-readable text.

Lot & Batch Numbers

Tracking production history accurately.

Expiry & Manufacturing Dates

Validating date formats and logic.

Regulatory Symbols

Recognizing CE marks, sterile indicators, and "do not reuse" icons.

Multilingual Instructions

Verifying translations against approved master text.

Validation Against Requirement Documents

The system doesn't just read the label; it understands the "Source of Truth." It automatically cross-
references extracted data against your Labeling Requirement Documents (LRDs) and Master Data files.