의료기기 이야기

The requirements for AI literacy per the European Artificial Intelligence Act (AIA) came into force on February 2, 2025. This was discussed in our webinar. To provide further guidance, the EU Commission published (May 7) an FAQ on this topic. AI Literacy Per the European AI Act AI Literacy Per the European AI ActAs medical device manufacturers increasingly integrate AI technologies, the respon..

식품의약품안전처에서 '인공지능기술이 적용된 디지털의료기기의 허가 심사 가이드라인 (민원인안내서)'를 개정하였다. ▶ 주요내용의료기기 구분기준 및 품목분류 - 기계학습 적용 디지털의료기기 소프트웨어에 대한 규제적 접근 - 디지털의료기기 판단기준 - 구체적인 범위 및 예시 - 디지털의료기기에 해당하지 않는 소프트웨어 관리방안 허가, 심사 방안 - 성능 또는 특성 기재방법 - 성능 및 임상적 유효성 검증 - 임상적 유효성 확인 - 첨부서류의 범위 - 변경허가, 인증 대상 - 훈련 데이터셋의 관리 식품의약품안전처>법령/자료>법령정보>공무원지침서/민원인안내서>민원인안내서 - 상세보기 | 식품의약품안전처

The 2025 International Symposium on Human Factors and Ergonomics in Health Care was held in Toronto and included upwards of 700 attendees across the 4-day program, including a day specifically dedicated to the second annual Healthcare Robotics Summit. The summit was a huge success, bringing together human factors practitioners, researchers, students and clinicians in a collaborative environment ..

Our webinar on the European Artificial Intelligence Act Regulation 2024/1689 emphasized the importance of risk categorization per the Medical Device Regulation (MDR, 2017/745) and In-Vitro Diagnostic Regulation (2017/746 IVDR) and the AI Act.The AI Act is now part of the new legislative frameworkThe AI Act is a new part of the new legislative framework and also applies to medical devices and IVD..

(출처: 한국의료기기협동조합)고대의료원 임상연구자원실에서 FDA 의료기기 관련 AI 규제 가이드라인 초안 지침을 번역/요약하여 발표하였다. ▶ 주요내용기기설명사용자인터페이스 & 라벨링위험평가데이터관리검증 (Validation)기기 성능 모니터링 사이버보안Public Submission Summary  [고려대의료원] FDA, 의료기기 관련 AI 규제 가이드라인 초안 지침 발표 – 한국의료기기협동조합 [고려대의료원] FDA, 의료기기 관련 AI 규제 가이드라인 초안 지침 발표 medinet.or.kr

Emergo에서 아래와 같이 웨비나를 개최한다.​▶ 주제: EU AIA and its inter play with the EU MDR/IVDR▶ 일시: 2025년 03월 20일 CST 9시 (한국시간: 03월 20일 23시)  The European Union issued the Artificial Intelligence Act (AIA), published as Regulation (EU) 2024/1689 in the Official Journal of the European Union on July 12, 2024. The regulation places additional requirements on manufacturers of AI-enabled devices. Medical device ma..

The FDA encourages the development of innovative, safe, and effective medical devices, including devices that incorporate Artificial Intelligence and Machine Learning (AI/ML).  The AI/ML-Enabled Medical Device List is a resource intended to identify AI/ML-enabled medical devices that are authorized for marketing in the United States (updated).  Artificial Intelligence and Machine Learning (AI/ML..

Emergo에서 아래와 같이 웨비나를 개최한다.​▶ 주제: The Role of AI in the Practice of Human Factors Engineering▶ 일시: 2024년 11월 20일 CST 9시 (한국시간: 11월 21일 00시) During this webinar, the presenters will briefly discuss the various medical technologies that incorporate AI features and/or machine learning. However, the focus will be on how AI of the chatbot variety can facilitate a wide range of analyses and writing eff..

This is the second in our series of regulatory updates on the EU AI Act. We discussed AIA in our first regulatory update, the EU Artificial Intelligence Act. The EU AIA introduces a comprehensive framework for AI-enabled device regulation in the EU. In this regulatory update we discuss key elements of the regulation and best practices, enforcement and oversight, AI regulatory sandboxes and real-..

In recent years, the FDA has embarked on an ongoing journey to develop a premarket review approach for artificial intelligence (AI)/machine learning (ML) software modifications. This journey included the Agency’s 2019 discussion paper and request for feedback on the proposed regulatory framework, several workshops to gather inputs from various stakeholders, as well as the Agency’s action plan re..