Suite of CE marked software and devices meet the new, stricter medical device standard.
SCOTTSDALE, Ariz. February 02, 2022 — GlobalMed, an international provider of virtual health solutions, is proud to announce that its eNcounter® telehealth software suite, ClinicalAccess® Station Lite and multiple diagnostic examination cameras are now compliant with the European Union’s (EU) strictest medical device regulation MDR 2017/745. EU-based Medical Technology Promedt Consulting GmbH issued the MDR 2017/745 certificate, effective December 2021, declaring that the submitted GlobalMed products conform to the outlined regulations and are approved to display the CE mark under this new standard which addresses both devices and software.
MDR is a new set of regulations that governs the production and distribution of medical devices in the European Union and will be mandatory for companies that want to sell these products in that marketplace. Compliance with this latest standard ensures that GlobalMed can continue to support the 27 EU member states with its software and hardware virtual telehealth solutions.
GlobalMed’s compliance with the new European medical device regulation expands its CE marked product offering to Europe, including the recently released TotalExam® Lite Exam Camera and Otoscope.
“Compliance with the new European medical device standard is another important milestone in our 20-year history, as we strive to make healthcare easily accessible to all individuals – regardless of where they call home,” said Joel E. Barthelemy, GlobalMed founder and CEO. “The demand for telemedicine solutions continues to grow across all markets, regardless of geopolitical boundaries. Compliance with MDR not only expands our ability to offer these solutions where they are most needed, but it also shows our commitment to adhering to a quality management system that ensures the performance of our solutions throughout their lifecycle.”
The EU MDR compliance expands GlobalMed’s offering into Europe, increasing its list of CE-Marked products to include telehealth stations, mobile solutions, telehealth software, digital stethoscopes, exam cameras, otoscopes, conferencing cameras and a range of other medical devices designed for virtual care.
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Kate Lunt
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