Category: Software as Medical Device – SaMD

USFDA – Review framework for artificial intelligence-based medical devices

Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices Artificial Intelligence and Machine Learning in Software as a Medical Device Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)

TGA – Regulation of Software as a Medical Device

Another hot topic, together with Cybersecurity, is SaMD (Software as a Medical Device). Updated information from TGA here – Regulation of Software as a Medical Device. Outro tema quente, juntamente com cibersegurança, é o SaMD (Software as a Medical Device). Informações atualizadas da TGA aqui – Regulation of Software as a Medical Device.