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.
https://vimeo.com/449368406/6f3885a3b9The OWLS lite was designed to treat Wagner 0-1 plantar ulcers. It is an easy off-the-shelf solution to early developing wounds. The pneumatic bladder helps to reduce shear in the foot portion. The plantar sections are made from diabetic-friendly materials and are easily removed to create additional relief at the wound site. OWLS lite is