Software medical device certified in under 8 weeks

Lipodema is condition without many products to help. LipoCheck wanted to change that.

LipoCheck had a working version of their mobile application which allowed Lipodema patients to record their health data and understand their condition better. This was great, but they knew they could provide more value to those dedicated users of their app.

This came with a price though. Providing more value meant more healthcare related features. This inevitably meant that they would be wading into the murky waters of regulatory enforcement as their app would most certainly come under the purview of the EU's Medical Device Regulations. Looking for an efficient way to give back to their users and still meet their requirements for medical device certification, the LipoCheck team reached out to us at Formly.

The primary concern for LipoCheck was moving quickly and understanding the regulatory process. We settled on using the Premium+ package, which gave the LipoCheck team full access to the Formly software platform along with weekly 1:1 meetings with our regulatory experts and a dedicated support channel. Onboarding was as simple as inviting the team members and everyone started work immediately.

Then they hit a snag.

After getting through a significant amount of work on their quality and regulatory documentation, the LipoCheck team heard news that they needed to adjust the product to meet new requirements from their insurance provider. Was this going to take months? Changing anything in regulatory is supposed to take a lot of time right?

Using the Formly software platform, the changes were implemented and documentation was updated in only a day. We refined the User Needs, Software Requirements, Software Architecture, and so they were able to jump into testing right away. With this we were able to be back on track for certification after a day.

"The software allowed us to work very quickly." says Anina Langhans, co-founder of LipoCheck. "Not only that, but the Formly team was amazing at walking us through all the processes so we understood how the entire certification process worked. I feel much more comfortable with our medical device certification."

The LipoCheck team dedicated part-time work each week and used weekly meetings to check testing reports and documentation. After 8 weeks of work, LipoCheck successfully registered their product on the German BfArM registry (DMIDS) and the Eudamed website.

"The eQMS made the approvals process incredibly easy. My team was able to review everything quickly and it helped us tie up all of our loose ends to ensure we were perfectly compliant when we registered."

By integrating Formly.ai, LipoCheck saw an 80% reduction in certification-related costs and expedited their launch timeline by at least 4 months, allowing them to bring their product to market faster.

Thanks to Formly's streamlined, AI-powered approach, LipoCheck was able to meet their certification goals in on time and within budget. Their experience is proof that small teams are not at a limitation when going through complex processes like medical device certification when the right tools and support are provided.

LipoCheck now has their CE mark for their LipoAlly product and are using the Formly software with eQMS to manage their data and device surveillance. This way, any additional compliance activities or changes to the device can be done quickly so software release cycles aren't affected by the team's new medical device compliance requirements.

LipoAlly is now available in Germany with plans to expand to Switzerland and the United States with the assistance of FormlyAI.