DoseMeRx is used by hospitals and health systems across the United States, Australia, Europe, Africa and South America. We comply with local regulations in each jurisdiction.
United States of America
DoseMe has received expert legal advice that DoseMeRx falls within the MDDS and clinical decision support (CDS) carve-outs of the enacted 21st Century Cures Act (2016), and is thus excluded from regulation as a medical device.
DoseMeRx is therefore exempted from 510(k) submission, however, is required to comply with the requirements of the 21st Century Cures Act (2016) and related legislation instead.
As DoseMeRx is registered as a medical device in Europe and Australia it is developed in accordance with FDA quality system regulations and software validation requirements for a software-based medical device. DoseMeRx will continue to follow these guidelines even though no 510(k) submission is required. This requires compliance to a number of standards, including IEC 62304, ISO 13485, ISO 14971 and 93/42/EEC Medical Device Directive. Due to DoseMe’s compliance with these and other legislation, DoseMeRx has a robust and detailed quality system.
DoseMeRx is a Class I medical device and complies with the requirements to maintain a listing on the Australian Register of Therapeutic Goods (#226237).
DoseMeRx is registered through the Dutch Competent authority, with registration NL-CA002-2014-32089. DoseMeRx conforms with CE Marking guidelines for a Class I medical device.
DoseMeRx is available in a number of other countries and jurisdictions, as many accept CE-marked medical devices or US clearance.