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Pascal Werner, MSc

Regulatory Affairs consultant
self employed

Pascal Werner 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 Werner to offer comprehensive regulatory services. He approaches solving complex regulatory and technical problems topics with a user-based mindset allowing for increased effectiveness. Pascal Werner studied biomedical engineering in Germany, Finland, and Malaysia with a focus on machine learning in healthcare. Prior to the current role he co-founded a startup that developed smartphone based hearing tests and sound personalization technology.

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