Empire Precision Plastics Adds In-line Serialization Capability for Medical Devices

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New technology will improve part traceability and aid compliance to FDA unique device identification regulations

medical device example pill camera

Empire Precision now offers in-line serialization of medical device components during manufacturing.

With this new capability, we can enable customers to meet UDI requirements with the least impact to part cost and delivery time.

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.

Empire is now quoting projects with laser marking and expects the rest of the expansion to be completed in the fall. Learn more at http://www.empireprecision.com.

Empire Precision Plastics (http://www.empireprecision.com) has a 20-year legacy of partnering with customers to solve their most challenging injection molding problems. Empire provides medical device, consumer, industrial and military/aerospace customers with plastic molded parts and optics, from prototype to high volume manufacturing and assembly. Their comprehensive in-house capabilities allow for faster time-to-market and better finished quality, improving profit margins for their customers. Empire Precision Plastics is ISO 9001:2008 and ISO 13485:2012 certified and ITAR registered.

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Neal Elli
Empire Precision Plastics
+1 (585) 454-4995 Ext: 112
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