With the development of new technology, more and more innovative medical devices are marketed, and clinical efficacy has become the focus of attention in the high-quality development of medical devices. The clinical efficacy of medical devices is mainly determined by the quality of research and development, and improving the R&D quality of medical devices effectively has been a starting point for the high-quality development of the medical device industry. This paper focuses on the research and development process of innovative medical devices, combining the Verification Guidelines of Medical Device Registration Quality Management System and the special approval requirements of innovative medical devices, proposes that manufacturers could integrate the regulatory requirements into the development of research and development technical routes, design validation, clinical evaluation to improve R&D the quality of innovative medical devices.