Team NB position statement on the requirements for the EU MDR/IVDR Notified Body Partners under the Technical Cooperation Program on Exchange of Medical Device Quality…
Posts published in “International Organization for Standardization – ISO”
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…
DECRETO Nº 10.229, DE 5 DE FEVEREIRO DE 2020
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…
EN ISO 14971:2019 was published today. For those wondering, both the ISO and EN versions were going to be published today, but ISO published the…
ISO 14971:2019 was published yesterday – see here: https://www.iso.org/standard/72704.html
ISO TC 210 JWG 1 “finished” today the monumental task we’ve been working for the past 3 years – the revision of ISO 14971 and…
QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; Town Halls Planned
Guidance on the Systematic Review process in ISO Guidance on new work My ISO job – What delegates and experts need to know How to…
A ISO 13485:2016 se encontra em processo de análise crítica sistemática (para maiores informações sobre o processo, favor acessar o guia Guidance on the Systematic…