Osseus Fusion Systems, Dallas, Texas, USA, reports that it has received ISO 13485:2016 certification with the Medical Device Single Audit Program (MDSAP), part of the U.S. Food and Drug Administration (FDA), which will reportedly allow the company to accelerate growth of its spinal fusion and fixation products in international markets.
Osseus is a medical device company specialising in advanced technology products for minimally invasive surgery. According to The International Organization for Standardization, ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Derek Holland, Vice President of Sales, Osseus Fusion Systems, commented, “We are excited to announce this ISO certification milestone and feel it exemplifies our drive for an impeccable level of quality and compliance. Additionally, with demand that already exists, we now have the opportunity to pursue international supply chains that give us incredible growth potential.”