American Banknote Company (ABCorp), one of many longest-standing manufacturing service suppliers in the US, has achieved ISO 13485:2016 medical machine certification of its Additive Manufacturing Middle (AMC) in Boston.
ISO 13485 is the internationally acknowledged customary for high quality administration programs (QMS) in designing and manufacturing medical units. It outlines particular necessities that assist organizations guarantee medical units meet each client and regulatory calls for for security and efficacy. ISO 13485 certification protects customers by making certain uniformity and high quality in medical machine manufacturing, enhancing affected person outcomes, and lowering danger and recall.
“Procuring ISO 13485 certification has been a high precedence for ABCorp, and we’re thrilled to announce this achievement,” stated Neil Glazebrook, VP of 3D Options at ABCorp. “Since its inception in 1795, ABCorp has prioritized high quality, security, and consumer service, all of that are considerably enhanced with ISO 13485 certification.”
ISO 13485 certification gives a number of advantages to sufferers, together with superior product high quality, value and danger discount, improved affected person satisfaction, and enhanced security. ISO 13485 certification additionally signifies the producer has carried out a complete QMS, enhancing belief and credibility amongst customers.
“ABCorp boasts a wealthy historical past of over 225 years, delivering very important items and providers to main companies in addition to federal, state, and native authorities entities throughout greater than 120 nations. The arrival of additive manufacturing, significantly 3D printing, grants our purchasers unparalleled design flexibility and is really revolutionary within the medical machine sector. This revolutionary expertise encompasses prototyping, becoming, and even extremely custom-made manufacturing – all of that are tremendously enhanced by ISO 13485 certification,” stated Glazebrook.
ABCorp’s AMC is positioned inside ABCorp’s safe facility, which spans 125,000 sq. ft and is provided with a number of HP Jet Fusion 5620 industrial programs, Jet Fusion 580 full-color printers, and Desktop Steel manufacturing printers. The vary of printed supplies consists of HP 3D Excessive Reusability PA 11, HP 3D Excessive Reusability PA 12 (together with PA 12 White), ForwardAM/BASF Ultrasint TPU01, HP 3D Excessive Reusability PP in collaboration with BASF, full-color HP 3D Excessive Reusability CB PA 12, in addition to stainless steels 174PH and 316L. Moreover, ABCorp gives ending providers using AMT’s PostPro3D smoothing expertise.
