Reptron MI Facility Receives Med. Device Certification
TAMPA, FL—The Reptron Electronics contract manufacturing facility in Gaylord, MI, has received ISO 13485:2003 certification. The company's Tampa facility received this certification in June 2004.
"This is an important milestone in our commitment to serving the specialized needs of our medical device manufacturing customers. This segment represents over 40% of our current business base. We are pursuing certification in all our facilities to enhance the geographic support flexibility we can offer our medical industry customers, both in terms of process consistency and ability to support our customers' multinational end market regulatory requirements," said Paul J. Plante, president and CEO.
The ISO 13485:2003 quality management system was published to ensure consistency in medical device manufacturer compliance to regulatory quality management requirements worldwide. It is based on quality management system requirements currently contained in medical device regulations around the world and also incorporates elements of ISO 9001:2000.
Additionally, the FDA has informed Reptron that the Gaylord facility is now registered as an EMS provider of medical devices. A similar announcement was made regarding the Tampa facility last year. [These registrations are not an FDA endorsement or approval.]
