ANZER, a full-service contract electronic designer and manufacturer has earned ISO 13485 medical manufacturing certification. ISO 13485 is an international standard that specifies requirements for a quality management system for medical devices. It outlines the processes and controls that medical device manufacturers must follow to ensure their products’ safety, reliability, and effectiveness.
“By expanding our accreditations of quality management certifications, we provide more answers (ANZERs) for our customers,” comments Dipti Mendpara, president. “Adding medical manufacturing qualifications to our other quality management expertise benefits all our customers. Enhancing quality practices is a fundamental reason customers choose to team up with us.”
With more than 30 years of experience producing electronic prototypes, printed circuit board assemblies (PCBA), and box-build products, ANZER provides complete made in the U.S.A. solutions. ANZER has experience in many industries, including commercial lighting, automation, and aerospace, with ISO 9001:2015 and AS9100:2016 certifications.
About ANZER
ANZER, based in Akron, Ohio, provides electronic contract design and manufacturing services to industrial corporations. Capabilities include complete box builds, subsystem assembly, and surface mount technology (SMT) manufacturing. Value-added services include wiring harnesses/cable assemblies, thru-hole and hand soldering, conformal coating, and potting services. Additional certifications include a Minority Business Enterprise (MBE) and a Women Business Enterprise (WBE). To learn more, please visit: Medical Electronics Assembly.
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