Plexus factory in Malaysia gets FDA clearance
September 27, 2007
Electronics manufacturing services (EMS) provider Plexus Corporation said today it has received approval of the US. Food and Drug Administration to manufacture class III medical devices at its plant in Malaysia.
Through its pre-market approval supplement evaluation process, the Neenah-based contract manufacturer of electronics products will produce class III finished devices for a large tier-one, medical original equipment manufacturer at its Penang, Malaysia, plant.
Class III medical devices, the most highly regulated class, are typically those medical devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury, according to the FDA.
Plexus has three FDA-registered manufacturing facilities in the United States, Mexico and Malaysia, two of which are are now approved to manufacture finished class III medical devices.