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[식약처, MFDS] 디지털의료기기 사용적합성 허가·심사 업무설명회(1차) 발표자료

식품의약품안전처에서 디지털의료기기 사용적합성 허가, 심사 업무설명회 발표자료를 개재하였다. 주요내용▶ 2025년 사업계획▶ 사용적합성개요▶ 디지털의료제품법 변경사항▶ 사용적합성 허가, 심사 가이드라인▶ 허가 심사 시 제출된느 사용적합성에 관한 자료 식품의약품안전처>법령/자료>자료실>학술 토론회 - 상세보기 | 식품의약품안전처법령/자료>자료실>학술 토론회 | 식품의약품안전처" data-og-description="디지털의료기기 사용적합성 허가·심사 업무설명회(1차) 발표자료 등록일 2025-04-29 조회수 441 디지털의료기기 사용적합성 허가·심사 업무설명회(1차) 발표자료 게시합니다. 첨부파일 첨부파일 " data-og-host="www.mfds.go.kr" data-og-source-url="htt..

Emergo에서 아래와 같이 웨비나를 개최한다.​▶ 주제: Determining when to utilize the pre-submissions Q-submission (Pre-Sub) Process▶ 일시: 2025년 03월 12일 CST 9시 (한국시간: 03월 12일 23시)  China’s medical product regulator, the National Medical Product Administration (NMPA), finalized their Human Factors (HF) guidance “Guidelines for the review of medical device usability engineering registration” in March 2024. The guidance..

Understanding pen-injector use errors and their implicationsThe proliferation of pen-injectors used by laypeople for self-administration of medication in their homes has caused regulators, such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), to task manufacturers with providing sufficient evidence to demonstrate that all users, especially laypeopl..

Why pilot tests are essential for usability studiesDeveloping a methodology for usability studies can involve uncertainty and introduce questions such as “How long should the test session last?,” “How can I improve my setup?” or “Is this prompt clear enough?” Running pilot test sessions prior to formal testing can help you find answers to these questions and increase the data quality of your upc..

Why a known problems analysis is crucial for NMPA complianceA known problems analysis (KPA) is a human factors engineering (HFE) activity that aims to identify use issues and user interface flaws with devices currently on the market. Regulators require medical device manufacturers to conduct a KPA to investigate use problems associated with devices that are similar to a device under development ..

Emergo에서 아래와 같이 웨비나를 개최한다.​▶ 주제: Open Forum: Human Factors Usability Testing Q&A▶ 일시: 2024년 08월 22일 CST 9시 (한국시간: 08월 22일 23시)  Usability testing is one of the most important activities you can perform during the development of your medical device. Usability testing results can help you determine user needs, better understand use-related risks, inform your design process, and demonstrate safer a..