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Regulatory consultation services for medical device

To enhance the regulatory knowledge of domestic medical device companies, the MDD is dedicated to assisting industry, academia, and research institutions in considering and planning for regulatory requirements early in the medical device development process. Our focus is on providing professional evaluation and advice on regulatory science strategies, preclinical testing, and clinical investigations related to market approval requirements. This helps developers find the appropriate regulatory pathways for their medical devices as early as possible. Our services include providing consultation and guidance on relevant Taiwanese and foreign medical device regulations. We assist various stakeholders in understanding and preparing regulatory submission documents that meet local requirements, thereby reducing the time and manpower costs associated with additional documentation. Concurrently, we aim to provide accurate and comprehensive documentation to improve the efficiency and effectiveness of the review process, thus accelerating the time to market for new products and promoting the development of the entire medical device industry.

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