As can be seen in the ISO 13485:2016 page on the ISO website – the standard is under systematic review. Systematic review is required for…
Posts published in “International Organization for Standardization – ISO”
ISO TC 210 JWG 1 met last week in Stockholm to discuss the last steps of the revision of ISO 14971 and ISO 24971. The…
Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials…
Um vídeo sobre a reunião em São Paulo do ISO TC 210 IEC SC 62A JWG 1 Aplicação da Gerenciamento de Riscos a Dispositivos Médicos…
ISO TC 194 just had the plenary 2018 meeting in Berlin. Next meeting will be in China, May 2020. A reunião plenária de 2018 do…