Orthomerica upgrades its Quality Management System and achieves ISO 13485:2016 with MDSAP Certification

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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. 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 regulatory jurisdictions including the US Food and Drug Administration (FDA), Health Canada, Australia, Brazil, and Japan. This recent achievement demonstrates Orthomerica’s 30-year commitment to providing safe and effective orthopedic devices that consistently meet the highest quality standards.

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