VITALS360® Vital Signs Monitor Certifications

The Vocare Vitals360® Vital Signs Monitor is the only device with the advantages of delivering Remote Patient Monitoring (RPM), Telehealth, or Point-of-Care solutions. With Cellular, Wi-Fi, and Bluetooth capability, the Vitals360® enables healthcare providers to remotely capture key clinical vital sign monitor measurements from a single mobile device. Data captured from the FDA Medical Device can be directly uploaded to a provider’s clinical information system.

VoCare has developed the Vitals360® Vital Signs Monitor, the world’s first multi-diagnostic telehealth, self-contained, patented, Class II FDA 510(k) Cleared, FCC-approved connected professional grade-medical device. Most Class II medical devices perform only one function. Class II medical device examples include blood glucose and ECG. Most Patient Monitor devices perform a single function. The Vitals360® vital signs monitor performs seven.

VoCare is certified ISO13485 via annual audits, which meet the FDA QMS standards for marketing in the U.S. and allows VoCare to sell in many other countries. The FDA recently published a rule to harmonize its medical device quality management system (QMS) regulation, 21 CFR Part 820, to the ISO 13485 QMS standard earlier this year.