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.
Orthomerica is proud to announce the launch of the AllSTAR team of cranial clinicians. This clinical network is made up of exceptional clinicians dedicated to the care of infants with deformational plagiocephaly and post-operative craniosynostosis using the STAR® Family of cranial remolding orthoses manufactured by Orthomerica Products, Inc. The AllSTAR clinical network was developed to