Pascal Werner
DTx/AI/SaMD/DiGA medical device regulatory consulting (Berlin and Raleigh, NC)
- Role
- Digital Health Regulatory Advisor at Digital Health Works
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
About Pascal Werner
Got (regulatory) questions or want to chat about DiGA/SaMD/DTx: https://calendly.com/regme/virtual-coffeePascal works as a freelance consultant for startups and small/medium enterprises on quality/integrated management systems, technical documentation, and regulatory strategy with a focus on digital therapeutics, digital health, AI, and SaMD.His expertise in software development and entrepreneurial thinking, combined with his knowledge of laws and regulations, allows Pascal to offer comprehensive regulatory services. He approaches solving complex regulatory and technical problems topics with a user-based mindset allowing for increased effectiveness. Pascal studied biomedical engineering in Germany, Finland and Malaysia with a focus on machine learning in healthcare. Prior to Mimi he offered training and consulting for new software implementation. In his private life Pascal is enjoying his golden retriever, travelling, and training for an Ironman.
Experience
Digital Health Regulatory Advisor
Sep 2023 — Present
Education
Universiti Teknologi Malaysia
Master of Engineering (M.Eng.), Biomedical Engineering
2011 — 2012
Technische Universität Ilmenau
Master of Science (M.Sc.), Biomedical Engineering
Skills
- Microsoft Office
- Matlab
- Management
- Forschung
- Marketingstrategie
- Social Media
- Geschäftsführung
- Management Consulting
- Start-Ups
- Marketing
- Projektmanagement
- Strategische Planung
- Strategic Planning
- Unternehmensstrategie
- Project Management
- Geschäftsentwicklung
- Unternehmensberatung
- Business Strategy
- Business Development
- Unternehmertum
- Unternehmensführung
- Strategisches Management
- Holacracy
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