ABCorp achieves ISO 13485:2016 medical device certification

American Banknote Corporation (ABCorp), one of the longest-standing manufacturing service providers in the United States, has achieved ISO 13485:2016 medical device certification of its Additive Manufacturing Center (AMC) in Boston.

ISO 13485 is the internationally recognized standard for quality management systems (QMS) in designing and manufacturing medical devices. It outlines specific requirements that help organizations ensure medical devices meet both consumer and regulatory demands for safety and efficacy. ISO 13485 certification protects consumers by ensuring uniformity and quality in medical device manufacturing, enhancing patient outcomes, and reducing risk and recall.

“Procuring ISO 13485 certification has been a top priority for ABCorp, and we are thrilled to announce this achievement,” said Neil Glazebrook, VP of 3D Solutions at ABCorp. “Since its inception in 1795, ABCorp has prioritized quality, safety, and client service, all of which are significantly enhanced with ISO 13485 certification.”

ISO 13485 certification provides several benefits to patients, including superior product quality, cost and risk reduction, improved patient satisfaction, and enhanced safety. ISO 13485 certification also indicates the manufacturer has implemented a comprehensive QMS, enhancing trust and credibility among consumers.

“ABCorp boasts a rich history of over 225 years, delivering vital goods and services to leading corporations as well as federal, state, and local government entities across more than 120 countries. The advent of additive manufacturing, particularly 3D printing, grants our clients unparalleled design flexibility and is truly revolutionary in the medical device sector. This innovative technology encompasses prototyping, fitting, and even highly customized production – all of which are greatly enhanced by ISO 13485 certification,” said Glazebrook.

ABCorp’s AMC is located within ABCorp’s secure facility, which spans 125,000 square feet and is equipped with multiple HP Jet Fusion 5620 industrial systems, Jet Fusion 580 full-color printers, and Desktop Metal production printers. The range of printed materials includes HP 3D High Reusability PA 11, HP 3D High Reusability PA 12 (including PA 12 White), ForwardAM/BASF Ultrasint TPU01, HP 3D High Reusability PP in collaboration with BASF, full-color HP 3D High Reusability CB PA 12, as well as stainless steels 174PH and 316L. Furthermore, ABCorp provides finishing services utilizing AMT’s PostPro3D smoothing technology.