Solectron announces ISO medical certification of Singapore facilities
Jun 20, 2006
Solectron Corporation announced two of its Singapore facilities have received ISO 13485:2003 medical certification. With these two new certifications at Solectron's Chai Chee and Kallang facilities, Solectron now offers medical device OEMs seven certified contract manufacturing sites.
This certification means the facilities meet the requirements for a quality management system for medical device manufacturing. Additionally, the certification indicates regulatory guidelines applicable to medical devices and associated services, as well as customer requirements, are in place.
"The medical device market is highly complex," said Les Schnoll, chief regulatory officer, Solectron. "ISO certification is an important process that allows customers to be confident that Solectron meets certain requirements. Our ultimate objective is to demonstrate regulatory compliance, including the FDA's Quality System Regulation, to each medical device client we serve."
As medical device manufacturers face increasing pressures to increase revenue and bring products to market faster and at lower costs, Solectron has focused on improving OEMs' competitive advantage by offering services that eliminate design defects, speed time-to-market and reduce lead times at the lowest total landed costs.