On June 5, 2018 Perry Johnson Registrars certified RhythMedix’s compliance to ISO 13485:2016 Medical devices quality management systems for design, manufacture, selling, and support of its cardiac monitoring devices and systems for use within the healthcare and medical Industry. International Standards Organization (ISO) is a worldwide federation of national standards bodies.
SO 13485:2016 specifies RhythMedix’s quality management requirements for design, development, production, storage, distribution, servicing, and final decommissioning and disposal of medical devices, as well as, requirements for service and technical support.
RhythMedix was certified for ISO 13485:2003 on May 11, 2015. RhythMedix is audited by a Perry Johnson Registrars each year for compliance to ISO 13485.