Third TT electronics site achieves medical standard
Three of TT electronics integrated manufacturing services five worldwide sites are now able to manufacture medical electronic systems, having qualified for ISO 13485:2003. The Rogerstone site, near Newport in South Wales, has joined the firm’s other certified sites in Suzhou, China and Perry, Ohio.
TT electronics’ divisional director, John Molloy, said: “TT electronics is focused on the manufacture of demanding, complex electronics systems in low-to-medium volumes. Medical instrumentation is a significant opportunity for us. The fact that we have achieved this approval at a third site is proof of our outstanding credentials in this market – and is evidence of our continuing investment in all of our sites around the globe." ??The Rogerstone plant already fulfils internationally recognised and demanding standards for the manufacture of aircraft flight electronics, automotive electronics systems and for supplying the rail industry. ?? All five TT electronics integrated manufacturing services facilities hold ISO9001. The ISO13485 standard goes beyond its requirements for issues associated with the production of products covered by demanding regulatory standards. These include the management promotion and awareness of regulatory requirements, controls in the work environment to ensure product safety, risk management during product development, specific inspection and traceability requirements, specific standards of documentation and process validation for sterile devices, and specific requirements for corrective and preventative actions. ? Rogerstone also conforms to the ISO14001:2004 environmental standard. www.ttelectronics-ims.com
