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.…
Posts published in “Day: December 10, 2018”
Continuing with the duodenoscope topic: Olympus Medical pleads guilty to failing to file events notice: Justice Department. Continuando com o tema do duodenoscópios: Olympus Medical pleads…
MHRA – Field safety notices – 03 to 07 December 2018. As a reminder, as part of Post Market Surveillance (PMS), manufacturers should track field…
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…
This goes back to the ongoing duodenoscopes problems related to design and reprocessing… Isso remonta aos problemas relacionados ao design e reprocessamento de duodenoscópios…. The…
The EU Commission published some new templates for Field Safety Notices related to the current medical device directives and MEDDEV 2.12/1 rev.8. template links are below (they…
Cybersecurity is and will be a hot topic in the medical devices field for a long time, as more and more devices are connected. Health…
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…
O ABNT / CB-026 é o comitê técnico brasileiro que lida com a maioria das normas relacionados a dispositivos médicos. Mais informações sobre a ABNT…