TGA presentation: How the TGA regulates software, 7 March 2019
Posts published in “Software as Medical Device – SaMD”
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…
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.…