Supporting a Start-Up on the journey to CE-marking

A MedTech start-up developing an AI-based medical device software approached me to guide them through the regulatory process.

With no internal regulatory writer, the team needed both strategic and hands-on support to prepare their documentation for Notified Body review.

I worked with the team from early product development to the final device submission, establishing all required regulatory documents and providing targeted training on clinical evaluation principles.

Together, we submitted the technical documentation on time and were able to respond promptly to all Notified Body questions — resulting in the successful CE marking of the device.

Now, we are continuing our collaboration by implementing an appropriate PMCF strategy to ensure ongoing compliance and clinical relevance.