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 Dovetail to navigate the certification process efficiently while meeting their regulatory requirements.
LipoCheck chose Dovetail'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 Dovetail'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.
Dovetail QMS Plus 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 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 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 Dovetail QMS Plus 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 Dovetail's continued assistance.
