Lille Eurasanté Conference
Françoise Schlemmer is giving a conference on EU regulations on medical. www.eurasante.com
Re-election of the Administrative Committee for 2 years
Re-election of the Administrative Committee for 2 years
MDEG meeting
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 [...]
An article in Clinica by Vibha Sharma :
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.
Code of Conduct enforcement :
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.
Code of Conduct Board :
The board members signed a confidentiality agreement to perform the follow-up of the auditors
Auditors Pool
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
Clinica – Amanda Maxwell wrote an article
Notified bodies dropping like flies? New-style authority audits cause near-50% cull
NB-Med meeting
The meeting will take place at the Metropole. Representatives of Notified Bodies, of the Industry association and from European Commission are participating.
Team-NB GA
The General Assembly of the association will take place at the Metropole.