USFDA – Statement about rates of duodenoscope contamination from preliminary postmarket data

Some words from the US FDA about the duodenoscope problem, based on the post-market data : Statement from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data Algumas palavras do US FDAsobre o problema dos duodenoscópios baseados nos dados […]

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.

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 predicate devices) is even more important than ever. Lista de Novembro 2018 de 510 (k) clearances. Com as recentes sugestões da administração da FDA sobre futuras mudanças do processo 510(k), […]

CAMD – Patient Safety – The Focus For All Competent Authorities For Medical Devices (CAMD) Members

The European Competent Authorities for Medical Devices (CAMD) network published a new post explaining the focus on Patient Safety – The Focus For All Competent Authorities For Medical Devices (CAMD) Members. A rede de Autoridades Competentes Européias para Dispositivos Médicos (CAMD) publicou um novo post explicando o foco na Segurança do Paciente – Patient Safety – […]

Medical Device Directives – New templates for Field Safety Notices published

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 can also be found at: https://ec.europa.eu/growth/sectors/medical-devices/guidance_en). A Comissão da UE publicou alguns novos modelos para Avisos de Segurança de Campo relacionados às diretivas atuais de dispositivos médicos e ao MEDDEV 2.12 […]