Lumi Docs is an AI-powered platform designed to help MedTech companies get new products to market faster, with less risk and cost. Our secret sauce? We analyse the massive pile of documents needed for CE marking, pinpoint any non-conformities, and suggest ways to fix them. LumiDocs is founded by experienced entrepreneurs, two of whom experienced the difficulty of developing compliant technical documentation, getting a slot with a responsive notified body, and the dire consequences of notified bodies flagging detailed non-conformities. As a response to issues with expensive consultants, Niklas and Mathias turned to developing an internal system for using LLMs to develop the documentation and obtain the company’s first medical device certification. Our team has combined 15 years of experience as founders and entrepreneurs, collectively raised more than 60M dkk, led teams of +20 people, scaled revenue for SaaS products targeted at large corporates and experienced with MDR and bringing medical devices to market. Lumi Docs is changing the paradigm in compliance consulting from a fully person-driven process to an automated process, saving costs and increasing quality.