Medical & Life Sciences
Complex Medical
Electronics Manufacturing
Qualitel is a fully experienced manufacturer of complex medical electronics devices that meet the demanding requirements of critical medical applications. As a leader in PCB and box-builds, our capabilities include Class I and II ultrasound technology, surgical instruments and vital monitoring systems. We are committed to building your products with a goal of the highest reliability, on-time delivery, and 100% customer satisfaction. Our services include circuit card assembly, functional testing, final box-build, product labeling and packaging for distribution. In addition, we also do repair and refurbishment.
Comprehensive Testing
Qualitel’s comprehensive testing services are industry leading. Unlike many electronics manufacturing services providers, we can help develop and test in-house in order to maintain the necessary controls to deliver high quality medical electronics and providing continued maintenance and test calibrations.
Compliance and Certifications
To ensure we meet the high standards required for manufacturing medical equipment circuit boards, Qualitel is ISO 13485:2016 compliant is FDA registered to provide a full range of electronics manufacturing services for the medical device industry. Our team maintain Device History Records (DHR) for all products build at Qualitel. In addition, our manufacturing employees are IPC-A-610 and J-STD-001 certified with a IPC-A-610 trainer on staff.
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Your trusted partner for high-reliability electronic manufacturing.
Address
2109 S Susan Street Santa Ana, CA 92704
Email / Web
sigmatronix.com
Phone
(714) 436-1618
Fax
(714) 436-1810