Suntron Announces cGMP Compliance and FDA Registration
April 19, 2012. Suntron Corp., a provider of integrated electronics manufacturing systems (EMS) and embedded computing solutions, has announced that its Phoenix facility is now cGMP compliant and FDA registered. These certifications, along with Suntron’s current ISO 13485 standard, ensure high quality throughout the medical manufacturing processes.
The Food and Drug Administration (FDA) has long mandated the safety and effectiveness of devices used in the medical industry. As an EMS company serving the medical market segment, Suntron has many customers that require strict quality requirements that follow FDA-Good Manufacturing Practice (cGMP) standards defined by the FDA 21 CFR (Code of Federal Regulations) Part 820 QSR (Quality System Regulation). This QSR forces manufacturers to implement a quality system for designing, manufacturing, packaging, labeling, storing, and delivering medical devices sold within the United States.
Some of Suntron’s available services in the medical market include box build, printed circuit board assembly, and large-scale system integration. Suntron contributes to customers' product design by providing concurrent engineering, design for manufacturing, and design for testability. Sustron reports that engagement of the Suntron engineering group early in the design process reduces variation, cost, and complexity, and assists customers in getting their product to market.
Suntron’s medical market applications include ultrasound and endoscopy products, oral cancer monitoring and diagnostics, neuroprosthetic electrical stimulations, and electrosurgical devices. In addition, Suntron manufactures patient monitoring and connectivity systems and hospital asset tracking systems.
“Suntron’s Phoenix facility’s recent cGMP compliance and FDA registration are a great help to our medical device customers,” says Tom Anderson, plant manager. “They allow us to ship products manufactured at Suntron directly to our OEM customers’ required locations.”
View earlier news: DSA815 Spectrum Analyzer Employs Digital IF Technology