Hamburg, Germany, Thursday 06 February 2020 10.00 CEST
GAIA AG, one of the first developers of digital therapeutics worldwide, announces its successful certification by TÜV Rheinland, an independent Notified Body. The certification was done according to DIN EN ISO 13485:2016, meaning GAIA AG now officially fulfils the regulatory requirements needed to supply digital therapeutics of higher regulatory classes.
“For over 20 years, patients worldwide as well as our peers in the medical field and our esteemed partners of top insurance providers to innovative pharmaceutical companies, have placed their trust in our R&D competencies and our expertise in the field of digital therapeutics,” says Dr. Mario Weiss, CEO of GAIA AG. “This is why we’ve always held ourselves to the highest standard when it comes to effectiveness, safety, and data protection. Countless clinical studies stand to prove this. We are now evermore proud and pleased that TÜV Rheinland also confirms our dedication to keeping high standards for our processes.”
GAIA has been committed to the professional development of Digital Therapeutics (German: Digitale Gesundheitsanwendungen (DiGA)) for over 20 years. As early as 15 years ago, the company also began conducting extensive clinical trials of their digital health programs to confirm their efficacy and safety. Furthermore, GAIA was the first developer ever to successfully achieve CE marking for a digital therapeutic. According to Dr. Weiss, the issue of data protection has always been a non-negotiable asset for the company: “We therefore welcome the current Digitale-Versorgung-Gesetz (DVG), Germany’s new law for digital health applications. The DVG requires the availability and distribution of digital therapeutics independent from the major U.S. suppliers”.