Winthrop, Maine – AMI announced today that its Quality Management System had been certified to the ISO 13485:2003 standard for Medical Devices. This achievement builds on the company’s longstanding commitment to investing in the infrastructure needed to support its customers’ requirements for superior quality. AMI has been ISO 9001 registered since 1997 and added AS9100 certification for aerospace work in 2015.
ISO 13485 was established as a set of requirements for a comprehensive quality management system for the design and manufacture of medical devices.
“Our certification to ISO 13485 is a significant milestone for AMI. It recognizes the robust processes for manufacturing developed here at AMI that serve our customers well including our growing medical device segment. With our depth of experience in electronics manufacturing and the continued influx of electronics into devices used in the medical field, this is a great fit and natural expansion of the services offered by AMI,” said Greg Boyd, president and CEO of AMI.
“The medical community has long been leveraging advancements in electronics and is beginning to utilize the connectivity found in Internet-of-Things (IoT)-related products. AMI is deeply involved in manufacturing IoT hardware and I expect our experience to benefit both companies developing traditional electronic devices as well as the newer suite of connected devices,” added Scot Story, AMI’s vice president of business development.
Founded in 1989, AMI’s (www.amiems.com) work is found worldwide in building security systems, solar energy equipment, aircraft instrumentation, industrial laser controls, LED lighting, industrial weather stations and a host of emerging products from high-tech startups. AMI’s manufacturing capabilities include printed circuit board assembly, cable and wire harness manufacturing, product testing, and final integration/box-build assembly. AMI has an Electronics Prototyping Center located in Somerville, Massachusetts and its headquarters and production facility is located in Winthrop, Maine.