Description de la formation

Regulatory specialists are integral to bringing novel medical devices to market. They require a breadth of managerial and interpersonal skills in addition to technical, clinical and legal knowledge.

The program offers career specialized training in Regulatory Affairs, Quality Management and Advanced Regulatory Affairs with particular focus on the European Medical Device Regulations. It addresses graduates interested in commencing a career in the regulation or quality control of medical devices and also targets those from complementary disciplines such as entrepreneurship, research and development, and management, seeking comprehensive and practical knowledge in this field.

Plan de la formation

Modules:

• Foreign Regulatory Affairs
• Combination Products
• Digital Health technologies and Security
• Research and Development
• Clinical Trial Design and Performance