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

March 6, 2019

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.

NEW! OWLS Distance Learning Courses

March 4, 2019

Two new OWLS courses are now available. Earn .75 ABC CEUs for each course. Learn more here.

AAOP Panel Discussion Recap

March 3, 2015

Important updates regarding new clinical research supporting cranial remolding therapy.

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Dear Parents, Physicians and Providers

May 7, 2014

Response to NYT’s Cranial Helmets Article on May 1, 2014

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