MDR/IVDR revisions – Team-NB LinkedIn Safety Campaign
The report shows that the campaign generated strong engagement and broadened discussions surrounding the MDR/IVDR regulations to a wider circle of professionals and stakeholders. It made complex regulatory issues more accessible and [...]
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 [...]
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