2. May 2019 - for immediate release
Egoo.health a healthcare technology company developing a home-use blood biomarker connected diagnostics platform for professionals and consumers announces that it has received ISO 13485:2016 certification from the Notify Body Presafe Denmark (DNV).
The ISO 13485:2016 standard for medical devices represents the requirements for a management system for the design and manufacture of medical devices. The certification scope "Manufacture and sales of optical electromechanical in-vitro diagnostic analyzers and reagents " covers the appropriate applicable operations related to Egoo.health's Quality Management System, which is continuously maintained and improved and supports the emerging technology company that design and manufacture the diagnostic Egoo Home System targeted at measuring clinical-grade biomarkers related to lifestyle diseases and chronic disease management.
The ISO certification is an internationally recognized standard. The FDA has announced its planned adoption of the ISO 13485:2016 standard to harmonize the Quality Systems aspect of the regulation of medical devices with the international standard.
“We are proud of the management system we have established and to receive this important certification for the processes related to manufacturing and sales of in vitro diagnostic medical devices (IVD),” says Pernille Veje, Vice President of QA/RA&E at Egoo.health.
Thomas Warthoe, CEO at Egoo.Health supplements: "This is an important milestone for the company as we strive towards finalizing our "personalized-diagnostics" platform and start market introduction of the products. The ISO certification is a prerequisite for receiving CE-mark and consequently to be able to start marketing the product".
Egoo.health expects to be able to finalize clinical programs and CE-mark towards the end of 2019 and will bring the product to market around that time.
Egoo is a medical platform that make it easy and inexpensive to analyze whole blood biomarkers at home. The user performs the analysis on a small device and subsequently gets the test result directly on their smartphone, where it is presented and compared to historical test results and other relevant data. A distinctive feature of the Egoo platform is that it combines several widespread analytical measurement principles, which provides the platform with versatility, flexibility and accuracy. The platform is designed to measure up to 80% of all known biomarkers in whole blood. Currently, Egoo is used for cardiovascular diseases, diabetes and inflammatory diseases. Read more at http://www.egoo.health
Egoo.health, CEO Thomas Warthoe, email@example.com, mobile (+45) 21 63 35 34