In February 2019, Orthomerica was certified to the newest version of the ISO 13485 standard under the Medical Device Single Audit Program (MDSAP) after successfully completing a 2 stage Quality Management System Audit.
ISO 13485:2016 is the internationally recognized standard for medical device quality management systems, designed to ensure organizations consistently meet customer expectations and regulatory requirements while prioritizing patient safety and product effectiveness.
In addition to the ISO 13485:2016 requirements, the new MDSAP program allows a recognized auditing organization to confirm a manufacturer’s compliance with multiple global regulatory jurisdictions including the US Food and Drug Administration (FDA), Health Canada, Australia’s Therapeutic Goods Administration (TGA), Brazil’s ANVISA, and Japan’s Ministry of Health, Labour and Welfare.
This milestone reflects Orthomerica’s continued investment in operational excellence, regulatory leadership, and continuous improvement. It further enhances the company’s ability to support clinicians and partners worldwide with trusted orthopedic and cranial remolding solutions. For more than 30 years, Orthomerica has combined innovation with a steadfast commitment to safety, consistency, and customer satisfaction.
