Ingela Mauritzon

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

Her regulatory work is rooted in the European system, with experience and networks extending into the United States and China. Through Fabola, she works with early- and growth-stage manufacturers on MDR and IVDR strategy, medical device and IVD qualification, clinical and performance evidence, AI validation, Notified Body readiness, ISO 13485 quality systems, technical documentation and external PRRC responsibilities.Her regulatory practice and academic research inform one another, while remaining institutionally separate. At Halmstad University, Ingela is a PhD researcher in Innovation Sciences studying AI governance in regulated systems. Her research includes fieldwork within the European medical device conformity-assessment system and examines how organisations and regulatory institutions respond to technological and regulatory change.Her work has been published in the Journal of Medical Internet Research, the European Journal of Innovation Management, the Chinese Journal of Medical Guide and JMIR Human Factors. Her research addresses topics including shadow AI in healthcare, paradoxical tensions in medical device governance and the use of AI in medical device conformity assessment.Ingela also works across European and Chinese MedTech networks through her regulatory practice and her involvement with the Sweden-China Trade Council.To discuss a regulatory engagement, contact [email protected].

Recent work

Selected publications on regulation, AI, healthcare and innovation.

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