September 27, 2007 — /PRNewswire/ — NEENAH, WI — Plexus Corp., a contract manufacturer of electronics products, today announced that one of its Penang, Malaysia facilities has received approval from the U.S. Food and Drug Administration (FDA), through its premarket approval (PMA) supplement evaluation process, to manufacture Class III finished devices on behalf of a large tier-one medical OEM. This approval comes following an extensive on-site audit in Penang by the FDA.
Dean Foate, CEO of Plexus, comments, “This approval is another significant milestone in our more than 20 year history of supporting the increasingly global outsourcing requirements of medical device OEMs. Plexus has three FDA registered manufacturing facilities in the US, Mexico and Malaysia, two of which are now approved to manufacture finished Class III medical devices. Additionally, four of our engineering facilities and six of our manufacturing facilities are also ISO 13485:2003 registered. With approximately a quarter of our annual revenues coming from product design, supply chain management and manufacturing services for medical device OEMs, Plexus is a leading contract manufacturer for the medical device industry.”
Andy Hyatt, vice president of Plexus’ medical sector, adds, “We believe Plexus is one of the first contract manufacturers to have an Asian facility with FDA approval to manufacture finished Class III medical devices. We understand how competitive the medical device market is, and are committed to developing scalable, global solutions that will create a competitive advantage for our customers in their end markets. We will continue to broaden our global service offering and expect to be registering additional facilities in Malaysia and the U.K. with the FDA over the coming year.”
About Plexus Corp. — The Product Realization Company
Plexus is an award-winning participant in the electronics manufacturing services (EMS) industry, providing product design, test, manufacturing, fulfillment, and aftermarket solutions to branded product companies in the wireline/networking, wireless infrastructure, medical, industrial/commercial, and defense/security/aerospace industries.
The company’s unique Focused Factory manufacturing model and global supply chain solutions are strategically enhanced by value-added product design and engineering services. Plexus specializes in customer programs that require flexibility, scalability, technology and quality. Plexus provides award-winning customer service to more than 100 branded product companies in North America, Europe, and Asia.
www.plexus.com
Source: Plexus Corp.