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Medical Device Expert News

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.…

USFDA – November 2018 510(k) Clearances

List of November 2018 510(k) clearances. With the recent suggestions by FDA management on future changes of the 510(k) process, keeping up-to-date with clearances (and potentially…

ECRI – 2019 Top 10 Health Technology Hazards

ECRI just published its annual Top 10 Health Technology Hazards, for 2019. More info here: 2019 Top 10 Health Technology Hazards. A ECRI acaba de publicar os…