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Plexus Approved for Class-III Medical in Asia
September 28, 2007 |Estimated reading time: Less than a minute
NEENAH, Wis. Plexus Corp. received approval to manufacture class-III finished medical devices at one of its Penang, Malaysia facilities from the federal food and drug administration (FDA). The devices are for a tier-one medical OEM.
Plexus passed an on-site audit and achieved class-III approval through the FDA's premarket approval (PMA) supplement. The company operates three class-III facilities in the U.S., Mexico, and Malaysia, said Dean Foate, executive officer. Plexus plans to register additional facilities with the FDA in Malaysia and the U.K. through 2008, added Andy Hyatt, VP, medical sector.
Plexus sees about 25% of annual revenues in product design, supply-chain management, and manufacturing services for medical device OEMs. It boasts four engineering facilities and six manufacturing operations with ISO 13485:2003 registration, along with the three class-III approved sites. To learn more about the company, visit www.plexus.com.