The Additive Manufacturing Center (AMC) of ABCorp in Boston has received ISO 13485:2016 certification, an internationally recognized standard for quality management systems in the design and manufacture of medical devices. With this certification, ABCorp demonstrates compliance with regulatory requirements for safety, traceability, and performance in the production of medical products.
ISO 13485 places particular emphasis on process control, risk management, and detailed documentation of manufacturing steps. These requirements are designed not only to ensure regulatory conformity but also to enhance patient safety. For ABCorp, the certification marks an expansion of its capabilities in the field of 3D printing for medical applications.
“Procuring ISO 13485 certification has been a top priority for ABCorp, and we are thrilled to announce this achievement,” commented 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.”
The AMC operates within a secured 125,000-square-foot facility equipped with industrial 3D printing systems such as the HP Jet Fusion 5620 series, the full-color Jet Fusion 580, and production printers from Desktop Metal. Materials processed include PA 11, PA 12, TPU, polypropylene, and stainless steel alloys such as 174PH and 316L. The facility also offers surface finishing using AMT’s PostPro3D technology.
“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,” added Glazebrook.
By combining additive manufacturing with certified quality processes, ABCorp is able to deliver prototypes, customized components, and small series for medical applications. 3D printing enables high design flexibility, shortened development times, and patient-specific solutions. With ISO certification, ABCorp strengthens its position in the regulated medical technology market and lays the foundation for future projects in a rapidly growing sector.
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