Ingela Mauritzon

Regulatory scientist and founder of Fabola. AI governance in regulated systems.

Ingela Mauritzon is the founder of Fabola, a specialist regulatory practice serving MedTech and IVD companies in Europe and China. She works with early- and growth-stage manufacturers on MDR and IVDR strategy, ISO 13485 quality systems, technical documentation, and external PRRC responsibilities, with particular focus on AI-enabled and software-based medical devices.Fabola operates two connected legs of work. The business leg supports manufacturers with regulatory strategy, market access, and continuous performance evidence for AI-enabled devices across the European and Chinese regulatory systems. The research leg examines how regulatory institutions embed and manage the tensions between innovation and protection, contributing methodology and evidence to the emerging field of AI governance in regulated systems.Ingela is a PhD researcher at Halmstad University, defending in 2027, with fieldwork inside European Notified Bodies and the medical device conformity assessment system. Her work is published in the Journal of Medical Internet Research, with forthcoming articles in the European Journal of Innovation Management and the Chinese Journal of Pharmaceutical Guide, published by the National Medical Products Administration (NMPA) of China. She sits on the board of the Sweden-China Trade Council.To discuss an engagement, contact [email protected].

Recent work

Recent and forthcoming papers on regulation, paradox, and AI.

• LinkedIn
• Email
• Google Scholar
• ORCID
• Link