Medical Device Solutions
Ensure safety and compliance with Cognex technology
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 systems to trace medical devices through the supply chain. The goal of the UDI initiative is to provide a foundation for safe and secure global distribution of the various classes of medical devices.
Properly marking and registering medical devices provides a faster method to identify faulty, recalled, or expired products. It also helps address issues such as counterfeiting and gives doctors and patients more confidence in the quality of the products used. Not abiding by these regulations will prohibit medical device manufacturers from importing, exporting, or selling products.
Even in the absence of regulations, medical device manufacturers need solutions that minimize the production of unsafe products and reduce costly product recalls. Machine vision, AI-based technology, barcode reading, and barcode verification technology help automate part and marking inspections, code reading, and code quality while ensuring medical device safety and compliance.