DECRETO Nº 10.229, DE 5 DE FEVEREIRO DE 2020
Posts published in February 2020
This is not related to medical devices or the MDR/IVDR, but the concept can be used for both (substituting the information for the ones in…
Notification of a Body in the framework of a technical harmonization directive – 13/02/2020
Notification of a Body in the framework of a technical harmonization directive – National Standards Authority of Ireland (NSAI)
Researcher considerations for medical devices – Meeting the evidence requirements for market authorisation
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…
Notification of a Body in the framework of a technical harmonization directive – DNV GL Presafe AS
New TGA Classification Rules for Software that is a Medical Device – IMPORTANT DATES
Accreditation Scheme for Conformity Assessment (ASCA) – Annual Report 2019
In Portuguese only – RESOLUÇÃO – RDC Nº 336, DE 30 DE JANEIRO DE 2020