Medical industry companies require an EMS partner that is experienced in the detailed quality, reliability and documentation requirements of regulatory agencies. Suntron is FDA registered, and we offer manufacturing facilities that meet the strict quality demands of the FDA’s Good Manufacturing Practice (cGMP) standards, defined by FDA 21 CFR Part 820 QSR. This QSR is a comprehensive standard that defines precise quality requirements for engineering, manufacturing, packaging, labeling, storage and delivery for medical devices sold within the United States.
In addition to our ISO 13485 quality standard, Suntron’s GMP registration allows the company to ensure the highest quality level throughout our manufacturing processes. Our GMP status further enhances our ability to support medical customers by shipping products manufactured at Suntron directly to the customer’s required location.
Medical Product Experience [ click here to expand ]
The medical industry requires the highest level of quality and reliability for their safety-critical products. Suntron has a proven track record of satisfying the demanding, federally-mandated requirements for a wide variety of medical devices.
If you would like additional information, please contact Suntron at firstname.lastname@example.org.