Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act
Posts published in “Day: September 25, 2019”
27% Will be Compliant? Survey Highlights Lack of Readiness for EU MDR
RESOLUÇÃO – RDC Nº 305, DE 24 DE SETEMBRO DE 2019 – Dispõe sobre requisitos para fabricação, comercialização, importação e exposição ao uso de dispositivos…
There’s a bit of discussion in Elsmar about EU MDR Classification Rule 11. – Please explain MDR Rule 11 to me. Please feel free to…