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nanoMAG Receives ISO 13485:2016 Certification

nanoMAG, developer of novel lightweight, high-strength, bioabsorbable magnesium alloy technology, has received ISO 13485:2016 Certification.

ISO 13485 is the standard that defines requirements for quality management systems. ISO 13485:2016 has a greater emphasis on risk management and risk-based decision making. It also reflects changes related to the increased regulatory requirements for organizations in the supply chain. It is a major update from the 2003 standard and is designed to respond to latest quality management system practices, including changes in technology and regulatory requirements and expectations. 

nanoMAG’s bioabsorbable BioMg® implants utilize alloying elements that are essential nutrients to the body, according to the company. Applications are projected for ACL, shoulder, craniofacial, foot, hand, spine, hip and femur fixation.

Source: nanoMAG