CASE STUDY
How coobi achieved CE marking in under six months
coobi supports people in coping with addiction through an innovative combination of technology and proven methods of therapy and aftercare. Their app helps users manage their recovery journey, understand their behavioral patterns, and maintain sobriety with the assistance of their healthcare providers through a comprehensive digital platform
8
Weeks to MDR certification
175
Messages provided with experts
€70K
Saved in costs
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 Formly. After evaluating multiple certification solutions, coobi chose Formly'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 Formly'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 Formly's eQMS 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 Formly is exactly what we wanted and what we needed. No BS, no fluff. Formly'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 Formly'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 Formly's software with eQMS 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.
Ready for market?
Let's start with a 30-minute discovery call. We'll tell you honestly whether we can help, and if so, what the shortest path looks like.