Oct 21 2009
Suntron Corporation, a leader in the area of integrated Electronics Manufacturing Solutions (EMS) and Commercial Off The Shelf (COTS) technology with six (6) North American production facilities, announced today they have received their International Organization for Standardization (ISO) 13485:2003 certification for their Southwest Operations in Phoenix, AZ.
ISO 13485:2003 emphasizes meeting regulatory as well as customer requirements, risk management and the ability to maintain effective processes specific to the safe design, manufacture and distribution of medical devices. Today, more medical OEMs are requiring their manufacturing partners to be held to the same high standards and Suntron is uniquely positioned to accept these traceability demands. http://www.suntroncorp.com
"We realize the importance of risk management in the entire life cycle of medical products," states Michael Seltzer, General Manager for the Suntron Phoenix facility. "Receiving the ISO 13485 certification proves our emphasis on a robust quality management system and shows our commitment to expand in the medical device industry."
Suntron's experience in medical device manufacturing includes oral cancer monitoring and diagnostic, neuroprosthetic electrical stimulation, cell analysis, cryolipolysis, angiographic systems, ultrasound, and corneal topography. Suntron's continued commitment in the medical industry is strengthened and enhanced by this most recent certification.