Abstract

The MedTech sector in the DACH region (Germany, Austria, Switzerland) is undergoing rapid digital trans formation, driven by regulatory complexity and innovation pressure. Cool AI, a Munich- based SaaS startup, aims to revolutionize compliance automation for MedTech startups by leveraging artificial intelligence (AI), natural language processing (NLP), and large language models (LLMs). This article presents a detailed market research analysis of Cool AI's positioning, value proposition, competitive landscape, and strategic roadmap. Drawing from internal project insights and external market data, we explore the regulatory environ ment, customer segmentation, market potential, and barriers to adoption. The findings underscore Cool AI's potential to become a leading RegTech solution in Europe's most regulated healthcare ecosystem.

DOI: doi.org/10.63721/25JCTC0120

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