Category: Software as Medical Device – SaMD
Webinar: An update on the consultation for the Regulation of Software, including Software as a Medical Device (SaMD)
TGA presentation: How the TGA regulates software, 7 March 2019
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)
New report from the National Institute for Public Health and the Environment – RIVM from the Netherlands – Apps under the medical devices legislation
Consultation: Regulation of software, including Software as a Medical Device (SaMD)
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.