소프트웨어 의료기기 허가 ·심사를 위한 연구개발 프로세스 연계 요구사항 분석 및 가이드라인 개발
Development of a Guideline and Requirement Analysis Aligned with the R&D Process for Software as Medical Device Approval
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As the market size of medical devices grows and the spread of information technology, including artificial intelligence, interest in software medical devices is growing. Many researchers are seeking to commercialize their software R&D achievements through licensing, and regulatory agencies are responding to this demand by estab- lishing a separate group of reviews for software medical devices and managing review procedures based on the IEC 62304 standard. However, due to the differences between the process in the R&D and the medical device approval procedure, it is challenging for individual researchers to effectively respond to the approval process. This study pro- vides guidelines for the documentation that should be elicited for authorization review in the software R&D process. By analyzing the requirements of the U.S. Food and Drug Administration (FDA) and the Ministry of Food and Drug Safety (MFDS) for medical device approval, we provide guidelines for responding to both U.S. and Korean regulatory agencies. We facilitate the preparation of researchers for licensing by presenting the requisite licensing documents at each of the six stages of research and development.
Abstract
As the market size of medical devices grows and the spread of information technology, including artificial intelligence, interest in software medical devices is growing. Many researchers are seeking to commercialize their software R&D achievements through licensing, and regulatory agencies are responding to this demand by estab- lishing a separate group of reviews for software medical devices and managing review procedures based on the IEC 62304 standard. However, due to the differences between the process in the R&D and the medical device approval procedure, it is challenging for individual researchers to effectively respond to the approval process. This study pro- vides guidelines for the documentation that should be elicited for authorization review in the software R&D process. By analyzing the requirements of the U.S. Food and Drug Administration (FDA) and the Ministry of Food and Drug Safety (MFDS) for medical device approval, we provide guidelines for responding to both U.S. and Korean regulatory agencies. We facilitate the preparation of researchers for licensing by presenting the requisite licensing documents at each of the six stages of research and development.
참고문헌 (16)
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