DIGICAP – Digitalizing the Conformity Assessment Process
DIGICAP - Digitalizing the Conformity Assessment Process The EU funded project starts with the aim of improving conformity assessment from individual files to a data-driven process through: ✔️ Structured, machine-readable dossiers instead [...]
Code of Conduct – Version 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 [...]
Team-NB statement on Revising the Medical Device Regulatory Framework
Team-NB adopted a high-level position statement outlining key concerns and proposed solutions for the revision of the EU medical device and IVD regulatory framework. The paper calls for a balanced, risk-based approach [...]
Team-NB position paper for participation in Expert panels
This paper is proposing the notified bodies’ outstanding scientific, technical and regulatory expertise for EMA expert panels. This valuable contribution would enhance regulatory clarity, strengthen expert advice and support safer, more innovative [...]
TEAM-NB
25 YEARS
45 MEMBERS