Neenah, Wis. Plexus Corp., a contract manufacturer of electronics products, has announced that one of its Penang, Malaysia facilities has received approval from the Food and Drug Administration (FDA), through its pre-market approval (PMA) supplement evaluation process, to manufacture class III finished devices for a large tier-one medical OEM. This approval follows an on-site audit in Penang by the FDA.
Plexus has three FDA registered manufacturing facilities in the U.S, Mexico and Malaysia, two of which are approved to manufacture finished class III medical devices. The company also has four engineering facilities and six manufacturing facilities that are ISO 13485:2003 registered. Plexus estimates that about a quarter of its annual revenues is derived from product design, supply chain management and manufacturing services for medical device OEMs.