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Introduction Software Applications (Apps) are significantly changing our way of living, helping in various aspects of our daily lives, including healthcare. Medical device software (MDSW) Apps cover an extensive variety of uses such as those intended to drive insulin pumps, detect and diagnose skin cancers (e.g. melanoma) etc. These apps are directly available on app platforms for download and u..

In our daily lives and also in the medical field, patients and healthcare professionals are increasingly using apps. On June 16, the European Commission (EC) published “MDCG 2025-4 Guidance on the safe making available of medical device software (MDSW) apps on online platforms.” While the EC has published several pieces of guidance on MDSW already (our next update will be on the MDCG 2019-11 rev..

FDA에서 'Digital Health' 제품관련 자주하는 질문에 대한 공식적인 답변을 게재 12개 자주하는 질문에 대해 답변 Digital Health Frequently Asked Questions (FAQs) | FDA Digital Health Frequently Asked Questions (FAQs) We encourage you to review our list of FAQs on this page and explore the FDA’s many publicly available resources online to help answer your general questions. www.fda.gov