October 4th, 2023: [Richardton, ND] Signum, LLC, an emerging leader in medical electronics and manufacturing solutions, is pleased to announce that the company’s Quality Management System has achieved ISO 13485:2016 certification, the first such certification by a North Dakota electronics company. Along with its previous ISO 9001:2015 certification, Signum is now dual certified, enabling it to provide design and manufacturing services to the highly regulated medical device industry.
ISO 13485 is an international standard which specifies a quality management system (QMS) for production of medical devices. Adherence to ISO 13485 standards indicates that a company’s processes and procedures meet the latest regulatory requirements specific to the medical device industry.
“Signum’s continued commitment to quality led to this evolution of our quality management system which includes more sophisticated processes, procedures, and controls and will produce higher quality outputs” said Doug Hauck, President of Signum. “At Signum our dedication to quality, technology, and superb customer service makes us stand out in a crowded field of custom engineering companies. Our achievement of ISO 13485 illustrates our willingness to continually improve for the benefit of our customers.”
About Signum
Signum, LLC is an embedded systems company with locations in Fargo and Richardton, ND. Signum provides Internet of Things (IoT) solutions, engineering services, and ISO certified manufacturing of electronics, to a wide range of industries including agriculture, construction, vehicle electrification, medical devices, aviation, and consumer electronics.
Signum's multi-disciplinary team of engineers is skilled in developing tailor-made electronics, device firmware, cellular connectivity, data delivery, cloud services, database, web, and mobile software solutions. The company’s circuit board assembly facility allows full integration of the product development process from conception to production making Signum the premier choice for all embedded systems needs.
Media Contact
Ed Schwind – Founder and Vice President
eschwind@signumiot.com
(701) 730-3806