Free Newsletter
Register for our Free Newsletters
Newsletter
Zones
Analysis, Inspection and Laboratory
LeftNav
Assisted/Independent Living
LeftNav
Clinical and Nursing Equipment
LeftNav
Design and Manufacture of Medical Equipment
LeftNav
Diagnostics Equipment, Monitoring and Test
LeftNav
Education, Training and Professional Services
LeftNav
Health Education and Patient Management
LeftNav
Health Estates Management
LeftNav
Healthcare Support and Information Services
LeftNav
Hygiene and Infection Control
LeftNav
IT and Communications in Healthcare
LeftNav
Materials
LeftNav
Medical Device Technology
LeftNav
Research and Development
LeftNav
Safety and Security
LeftNav
View All
Other Carouselweb publications
Carousel Web
Defense File
New Materials
Pro Health Zone
Pro Health Zone
Pro Security Zone
Web Lec
Pro Engineering Zone
 
 
News

Malaysian contract manufacturing facility is cleared by FDA to produce class III finished medical devices

Plexus Corp UK : 26 November, 2007  (New Product)
Plexus has announced that one of its Penang, Malaysia facilities has received approval from the 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 OEMs.
The approval comes following an extensive on-site audit in Penangby the FDA.

Dean Foate, chief executive officer of Plexus, commented, 'This approval is another significant milestone in our 20 year history of supporting the increasingly global outsourcing requirements of medical device OEMs. Plexus has three FDA registered manufacturing facilities in the USA, 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, added, '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 UK with the FDA over the coming year.'
Bookmark and Share
 
Home I Editor's Blog I News by Zone I News by Date I News by Category I Special Reports I Directory I Events I Advertise I Submit Your News I About Us I Guides
 
   © 2012 ProHealthServiceZone.com
Netgains Logo