Sempre na vanguarda da formação de alto valor técnico
para profissionais da área Pharma , MedTech
e Suplementos Alimentares
PRÓXIMAS FORMAÇÕES
ÚLTIMAS NOTICIAS
EU MDR Update: New Harmonised Standards for Medical Devices
The European Commission has published Implementing Decision (EU) 2026/2479, introducing an important update to the harmonised standards supporting Regulation (EU) 2017/745 (MDR).
Clinical evidence for orphan in vitro diagnostic medical devices
This document provides guidance to manufacturers, notified bodies, expert panels, health institutions, and regulators on the clinical evidence requirements for orphan IVDs and for IVDs that have an orphan indication within the meaning of this guidance. The...
Questions and answers for marketing authorisation holders/applicants referral on nitrosamine impurities in human medicinal products
The European Medicines Agency (EMA) has released Revision 24 of its nitrosamine Q&A, introducing several important updates: https://lnkd.in/gAvk967S
TEAM NB Code of Conduct for Notified Bodies vs 5.3
Team-NB members adopted, at the unanimity of the presents, an updated version od the Code of conduct including a new paragraph requiring notified bodies to have a QMS process to investigate suspected certificate falsification or misuse, preserve evidence, take...
Comprometidos com a qualidade e a inovação.
