The plenary meeting will take place with the participation of Team-NB representatives. The agenda includes topics such as the legislative Issues with among others the state of Play concerning the revision of MDD, AIMDD and of the IVD Directive and the state of Play concerning the PIP Action Plan with the new Implementing Regulation on [...]
EU medtech notified bodies face code compliance audits Team-NB has completed the first audit to check whether its member companies are following the association's code of conduct.
The first audit in relation to the enforcement of the Notified Body Code of Conduct was executed in December 2013, this is the first of a planned sequence of audits which will continue in 2014 and beyond.
The board members signed a confidentiality agreement to perform the follow-up of the auditors
5 experimented auditors in the medical devices field signed contract with Team NB in the framework of the Code of Conduct audits. Namely the auditors are : Bodo Mestmacher Jos Kraus Johann Rader Peter Ruys Poul Schmidt-Andersen
Notified bodies dropping like flies? New-style authority audits cause near-50% cull
The meeting will take place at the Metropole. Representatives of Notified Bodies, of the Industry association and from European Commission are participating.
The General Assembly of the association will take place at the Metropole.
Dr Gert Bos is giving a conference in the framework of the Workshop on MDD Revision Unplugged.
Team-NB, a Notified Body organisation, and important criteria to consider in selecting a Notified Body.
