The Challenge
coobi developed a mobile application called 'coobi care' to help people with addiction disorders track their recovery journey and receive timely interventions, with the goal of reducing relapse rates.
Facing EU Medical Device Regulations compliance requirements, coobi needed an efficient path to certification while maintaining development momentum, leading them to partner with Dovetail. After evaluating multiple certification solutions, coobi chose Dovetail's Premium package, which provided access to the platform, weekly meetings with regulatory experts, and dedicated support.
The coobi team worked a few hours each week with Dovetail's experts through direct chat, creating specifications and testing reports. After just 8 weeks, they successfully registered their app on the German BfArM registry and EUDAMED website.
By leveraging Dovetail QMS Plus and expert guidance, coobi reduced certification costs significantly and accelerated their timeline by several months, allowing them to bring their solution to market faster to help patients in need.
Our package with Dovetail is exactly what we wanted and what we needed. No BS, no fluff. Dovetail's services are straight to the point and the team is so pleasant to work with. As a small business and a startup, that's what you really need.
The Solution
With Dovetail's AI-powered approach and expert support, coobi successfully achieved their certification goals on time and within budget, demonstrating that small teams can navigate complex regulatory processes when equipped with the right tools.
coobi has obtained the CE mark for their coobi care product and continues to use Dovetail QMS Plus to manage their data and device surveillance, ensuring efficient handling of compliance activities without disrupting software release cycles.
The coobi care application is now available in Germany, with plans to expand across Europe to help more individuals on their recovery journey from addiction disorders.
