Why choose a Cranial Remoulding Orthoses / Helmet Manufactured by Orthomerica ?
There are a number of reasons why Orthomerica products are prescribed. By virtue of being the world’s largest headband manufacturer, Orthomerica’s experience is unmatched, having now treated over 40,000 babies worldwide. Orthomerica has a highly skilled, experienced cranial support team who manufacture the highest quality researched cranial remoulding orthoses. is an authorised FDA registered Medical Device Manufacturer, fully compliant with the US FDA Quality System Regulation (QSR) and its Current Good Manufacturing Practices (CGMP). Currently, Orthomerica has four 510K’s under which the FDA permits Orthomerica to produce multiple designs of Cranial Remoulding Orthoses. This represents twice the number of 510K’s held by any other manufacturer worldwide. Furthermore, Orthomerica is certified to ISO – 9001, the International Standard for Quality Systems. Orthomerica is very fortunate to have two clinical education managers on staff who are published and nationally recognised speakers i
