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Pascal Werner

Digital Health Regulatory Advisor at Digital Health Works

Pascal Werner is a seasoned professional in the field of digital health and medical device regulation, currently serving as a Digital Health Regulatory Consultant at regulatory.me since November 2018. In this role, Pascal specializes in medical device certification, data privacy/security, and various regulatory frameworks including MDR and DiGAV/DiGA. Additionally, Pascal holds advisory positions at Prodct, a firm dedicated to supporting emerging biotech and medical device companies, and serves as a Digital Health Regulatory Advisor for Digital Health Works. Previously, Pascal co-founded Mimi Hearing Technologies GmbH, focusing on data privacy and medical product certification, and has held roles such as Managing Partner at campus application consulting GbR and Design Thinking Intern at Deutsche Bank. Pascal's educational background includes a Master of Science in Biomedical Engineering from Technische Universität Ilmenau and a Master of Engineering in Biomedical Engineering from Universiti Teknologi Malaysia.

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Raleigh, United States

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Digital Health Works

Digital Health Works is a commercialization agency. We're based in Massachusetts with affiliate offices in Berlin and Lisbon. We’re actively involved in the process of bringing digital health and medical technology products or services to the market, connecting innovations with the people who need them most.


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