How LipoCheck got certified with FormlyAI
Lipodema, chronic care
Software
Mobile App
Class I
70k€Saved according to alternative quotes
8Weeks from 0 to registered device
0Non-compliances
The Challenge
LipoCheck developed a mobile application for Lipodema patients to record health data and better understand their condition, but recognized they needed to add more healthcare-related features to provide greater value to their users.Adding these features meant their app would fall under the EU's Medical Device Regulations, prompting LipoCheck to partner with Formly to navigate the certification process efficiently while meeting their regulatory requirements.LipoCheck chose Formly's Premium+ package, which provided full access to the platform, weekly meetings with regulatory experts, and dedicated support, allowing their team to begin work immediately after a simple onboarding process.Midway through their documentation process, LipoCheck faced a challenge when they needed to adjust their product to meet new insurance provider requirements, but using Formly's platform, they implemented changes and updated documentation in just one day.The LipoCheck team dedicated part-time work each week with weekly meetings to review testing reports and documentation, successfully registering their product on the German BfArM registry and Eudamed website after just 8 weeks.Formly's eQMS streamlined the approvals process, making it easy for the team to review documentation and ensure compliance for registration, resulting in an 80% reduction in certification costs and accelerating their launch timeline by at least 4 months.
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.
Anina LanghansCo-Founder & Product Lead LipoCheck
The Solution
With Formly's streamlined, AI-powered approach, LipoCheck successfully achieved their certification goals on time and within budget, demonstrating that small teams can effectively navigate complex medical device certification processes with the right tools and support.LipoCheck has obtained the CE mark for their LipoAlly product and continues to use Formly's software with eQMS to manage their data and device surveillance, ensuring that additional compliance activities or product changes can be handled quickly without disrupting software release cycles.The LipoAlly application is now available in Germany, with plans to expand to Switzerland and the United States with Formly's continued assistance.
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