Chinese plant receives medical device approval

The plant in Suzhou, China site is the second TT electronics site to be qualified to ISO13485:2003, the other being its Ohio, USA site.

The TT electronics integrated manufacturing services Suzhou, China site is now qualified to ISO13485:2003 for the manufacture of printed circuit board assemblies, cable assemblies and integrated box build for medical devices.

It is the second TT electronics site to achieve this demanding standard, the other being its Ohio, USA site.

According to TT electronics Suzhou Managing Director, John Molloy: "The achievement of this exceptionally rigorous qualification at our site demonstrates the very high standards that we achieve here".

"In addition to being a requirement for the medical market, ISO13485 will give all of our customers great confidence in the quality and integrity of our processes at Suzhou".

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.

Molloy adds: "At Suzhou we offer the benefits of manufacturing in a low cost economy to consistent high quality standards".

"We can offer our 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 integrated manufacturing division of TT electronics has five manufacturing sites around the world: the USA, Malaysia, China and two in the UK.

Its 15,000m2 Suzhou site employs 650 staff.

In addition to ISO13485:2003 it holds ISO9001:2000, TS16949:2002, is UL certified on wiring harnesses and drawer connectors for use in data, signal control and power applications, conforms to the ISO14001:2004 environmental standard and uses Six Sigma processes.

It is also fully RoHS compliant.

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