Electronics Production | July 31, 2006

Solectron adds its seventh ISO13484 plant

Solectron Corporation today announced its FinePitch facility in Fremont, Calif. has received ISO 13485:2003 medical certification. The standard specifies requirements for a quality management system for regulatory purposes in the manufacture of medical devices.
In addition to FinePitch, the following Solectron sites have received ISO 13485:2003 certification:

* Chai Chee, Singapore
* Charlotte, North Carolina
* Dunfermline, Scotland
* Kallang, Singapore
* Sherbrooke, Quebec, Canada
* Suzhou, China

Solectron's FinePitch Technology operations provide emerging and established businesses with prototyping and new product introduction solutions to facilitate time-to-market and low-volume, high-mix manufacturing services for many industries, including medical devices.

"The medical device sector relies heavily on small runs of product during the regulatory approval process and for clinical trials," said Les Schnoll, Chief Regulatory Officer, Solectron. "Solectron's FinePitch business provides OEMs with a focused team of engineers that can assist them in early-stage product development and prototyping. The ability to protect customers' intellectual property while providing added engineering resources reduces the time for product development and is critical to helping medical device firms speed time-to-market with safe and effective products."

Solectron offers OEMs extensive experience in medical device manufacturing and applies its deep expertise to meet OEMs' needs. All of Solectron's medical manufacturing facilities -- including those in cost-competitive geographies -- are certified to ISO 13485:2003 and are compliant with the FDA's Quality System Regulation.


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