In-line serialization capability for medical devices

Rochester, New York – Empire Precision Plastics has added laser marking to its range of capabilities in order to better meet customer needs for precision molded parts and assemblies. The company can now offer in-line serialization of medical device components during the manufacturing process.

Today many medical device manufacturers are turning to polymer components in order to drive down costs and improve product safety. In-line serialization helps to ensure part safety by improving traceability and aiding compliance to the Food and Drug Administration’s unique device identification (UDI) regulations. As an ISO 13485:2012 certified manufacturer, Empire complies with all FDA identification and traceability standards, and this new marking option will reduce cost and add design flexibility for customers.

With in-line laser engraving, components can be inspected and approved prior to applying the serialization number, eliminating waste, paperwork and cost. When used with tracking software, in-line serialized components are instantly entered into the electronic tracking log. This eliminates manual entries, which saves time and prevents clerical errors which can be quite costly during an FDA audit. This technology also helps manufacturers avoid the added engineering and retooling costs of serializing through redesign.

“Unique serialization is important to our customers in regulated industries such as medical devices,” Empire Precision CEO Neal Elli said. “With this new capability, we can enable customers to meet UDI requirements with the least impact to part cost and delivery time.”

In addition to this new capability, Empire is investing in expanding its facility in order to streamline product flow and improve efficiency. This expansion includes a new white room for medical molding and assembly, as well as new injection molding and automation systems.

Source: Empire Precision Plastics