Due to the coronavirus (COVID-19) outbreak, ISO/TC 194 Biological and clinical evaluation of medical devices that were going to take place in May in China…
Posts published in “ISO TC 194 – Biological and clinical evaluation of medical devices”
So finally the FDIS of ISO 14155:2020 (edition 3) is out. The ballot ends April 01, so if everything is ok, we will probably have…
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…
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…