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 “ISO 13485”
QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; Town Halls Planned
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…
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…