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Pascal Werner
Digital health regulatory consulting based on own startup experience (Berlin and Raleigh, NC)
Professional Background
Pascal Werner is an innovative and ambitious professional in the field of biomedical engineering, leveraging his extensive background to navigate the complex landscape of medical product certification and data protection. As a co-founder of Mimi Hearing Technologies, he played a pivotal role in developing cutting-edge smartphone-based hearing tests and sound personalization technologies. His unique blend of software development skills and entrepreneurial spirit has proven essential in managing regulatory topics that affect the healthcare industry. With an acute understanding of laws and regulations concerning medical devices, Pascal has positioned himself as an indispensable resource for organizations looking to comply with necessary standards and protocols.
Pascal's approach is characterized by a user-centered mindset, which allows him to tackle intricate regulatory and technical challenges effectively. This mindset, coupled with his dedication to enhancing user experience, has resulted in the creation of innovative healthcare solutions that seamlessly integrate technology with user needs. Before his impactful role at Mimi Hearing Technologies, Pascal gained valuable experience by providing training and consulting services for new software implementations, enabling healthcare companies to enhance their operational frameworks and transition smoothly to innovative approaches.
Education and Achievements
Pascal's educational background laid a strong foundation for his career in biomedical engineering. He pursued a Master of Science (M.Sc.) in Biomedical Engineering at the esteemed Technische Universität Ilmenau, Germany, where he honed his analytical skills and deepened his understanding of the interface between technology and healthcare. His academic journey also included a Master of Engineering (M.Eng.) in Biomedical Engineering at Universiti Teknologi Malaysia, further enriching his perspective on global healthcare innovations and practices.
Additionally, Pascal had the opportunity to work as a Research Assistant at Aalto University School of Science and Technology, where he engaged in groundbreaking research that contributed to advancements in the field. His practical experience was expanded during a Design Thinking Internship at Deutsche Bank, teaching him the importance of user-centric design in product development.
Achievements
Throughout his career, Pascal has demonstrated a commitment to advancing healthcare technology. At Mimi Hearing Technologies, he played a crucial role in ensuring that their product met regulatory requirements, which included navigating the complexities related to data privacy and medical product certification. His efforts significantly contributed to the company's mission to provide accessible hearing solutions for everyone.
Moreover, serving as a digital health regulatory consultant at regulatory.me, Pascal is positioned to assist a wide range of clients in understanding and applying the regulations governing digital health technologies. His expertise has made him a sought-after advisor in the industry, guiding startups and established companies alike through the regulatory landscape of medical technology.
In his personal life, Pascal is a proud owner of a golden retriever and enjoys outdoor activities, particularly traveling and training for an Ironman. His well-rounded lifestyle reflects his dedication not only to his profession but also to maintaining a balanced and fulfilling personal life.