Experts on demand make certification a breeze

Addiction disorders affect millions of people worldwide, with limited digital tools available to support recovery. coobi wanted to change that landscape with their innovative app.

coobi had developed a working prototype of their mobile application coobi care that allowed people with addiction disorders to track their recovery journey, understand their behavioral patterns, and receive timely interventions. Their vision was clear - to reduce relapse rates and provide continuous support when users needed it most.

However, they knew healthcare-related features would land them in medically regulated territory. Their app would need to comply with the EU's Medical Device Regulations. Looking for an efficient path to certification while maintaining their development momentum, the coobi team reached out to Formly.

The main priority for coobi was understanding the regulatory landscape while moving quickly toward certification. 

Their big challenge? coobi restricted by time and needed to achieve certification as fast as possible.

Their team had spent months testing different certification solutions to find what might work best for them. Finally, they decided that Formly was their best option to get their documentation created with the quality and speed they needed. They were glad they did.

We recommended our Premium package, giving the coobi team full access to the Formly platform along with weekly 1:1 meetings with our regulatory experts and dedicated support.

"The software made the whole process super straightforward," says Julian Kruse, co-founder of coobi. "Not just the platform, but the Formly team was amazing at walking us through everything so we actually understood what we were doing. I feel so much more confident about our medical device certification now."

The coobi team dedicated a few hours each week and the direct chat with Formly experts to review, create specifications, testing reports and all other documentation they needed. After just 8 weeks of focused work, coobi successfully registered coobi care on the German BfArM registry and the EUDAMED website.

coobi leveraged the Formly direct chat better than anyone. Being able to work asynchronously with our experts meant they had answers to questions and expert guidance instantaneously while working through their documentation. This ensured their first draft of documentation was of the highest quality and kept their work flowing along seamlessly so their certification goal was never in doubt.

"The eQMS made approvals ridiculously easy. My team could review everything quickly, and it helped us make sure everything was compliant when we registered."

By working with Formly, coobi saw a substantial reduction in certification costs and accelerated their timeline by several months, allowing them to bring their solution to market faster and helping patients who needed it.

Thanks to Formly's streamlined, AI-powered approach and expert support, coobi achieved their certification goals on time and within budget. Their experience demonstrates that small teams can successfully navigate complex regulatory processes like medical device certification when equipped with the right tools and support.

coobi now has their CE mark for their coobi care product and continues to use the Formly software with eQMS to manage their data and device surveillance. This ensures that any additional compliance activities or product changes can be handled efficiently without disrupting their software release cycles.

coobi care is now available in Germany with plans to expand across Europe and help more individuals on their recovery journey from addiction disorders.