ISO 13485:2016 represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices, thus ensuring product safety and effectiveness.
To receive certification, organizations must demonstrate that their medical devices and related services consistently meet customer and regulatory requirements.
“This is a significant milestone for DiaMonTech on our path to transition from a tech startup with high ambitions and a bold vision, to a truly disruptive medtech company,” states Dr. Jenny Kegel, who is responsible for the quality management system at DiaMonTech.
ThorstenLubinski, CEO, adds: “This certification gives the entire team a substantial step forward in our mission to deliver a non-invasive glucose monitor to every person in the world with diabetes and enhance their quality of life significantly.”
The ISO 13485:2016 certification is considered to be the initial stepfor DiaMonTech to move forward with CE certification of its products with respect to the requirements of the new Medical Device Regulation (MDR) in theEuropean Union and paves the way for further innovation and development in the company’s plans to provide handheld and wearable health monitoring devices inthe near future.
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Founded in Berlin, Germany in 2015, DiaMonTech AG is a medical technology company committed to improving health outcomes for diabetics and empowering them to take control of their lifelong health. Its pioneered and patented non-invasive “no prick” photothermal detection technology is fast, painless and doesn’t require needles or test strips.
An industry first, DiaMonTech monitors the actual glucose molecules in skin, providing users with a more comprehensive and accurate reading comparable to invasive commercial devices.
With the D-BaseDiaMonTech achieved 99.1% accuracy in a clinical study with 100 people studied, received the CE mark as an approved medical device in April 2019 and is currently preparing FDA approval. To support its mission, DiaMonTech is led by a world-class team of scientists, researchers and healthcare experts.
About DiaMonTech
Founded in Berlin, Germany, in 2015, DiaMonTech is a medical technology company committed to improving health outcomes for people with diabetes and empowering them to take control of their lifelong health. Its pioneered and patented non-invasive “no prick” photothermal detection technology is fast and painless and doesn’t require needles or test strips. An industry first, DiaMonTech monitors the actual glucose molecules in skin, providing users with a more comprehensive and accurate reading comparable to invasive commercial devices. DiaMonTech achieved 99.1% accuracy in a test study with 100 people studied, received the CE mark as a medical device in April 2019 and is currently under FDA review. To support its mission, DiaMonTech is led by a world-class team of scientists, researchers and healthcare experts.
More information about DiaMonTech can be found at www.diamontech.de.
Press contact
Markus Teuber
E-mail: hello@diamontech.de
