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TT electronics integrated manufacturing services today announced that its Suzhou, China site has qualified to ISO 13485:2003 for manufacturing printed circuit board assemblies, cable assemblies and integrated box builds for medical devices. It is the second TT electronics site to achieve this demanding standard, the other being its Ohio, USA site.

TT electronics Suzhou managing director, John Molloy said, "Achieving this exceptionally rigorous qualification demonstrates the very high standards at our site. In addition to being a requirement for the medical market, ISO 13485 gives all our customers great confidence in the quality and integrity of our processes at Suzhou."

The ISO13485 standard goes beyond ISO9001 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.

Molloy continued, "At Suzhou we offer the benefits of manufacturing in a low-cost economy to consistent high-quality standards. We offer customers the benefits of dealing with an account management team based in Western Europe or the USA, the financial stability of a major UK listed company and the flexibility to resource logistical and manufacturing solutions globally."

The TT electronics manufacturing division of has five sites around the world: the USA, Malaysia, China and two in the UK.

Source: EMSNow Online