Surprise!
Unannounced notified body audits Commission recommendation finally issued medicaldeviceslegal
ENVI vote
The compromises developed in the ENVI group, have been mostly endorsed in the ENVI vote yesterday.
Commission published 2 documents
• A Regulation on the designation and the supervision of notified bodies • A Recommendation on the audits and assessments performed by notified bodies
Preparing for unannounced EU regulatory inspections – are you ready?
11 September 2013 - Amanda Maxwell
CoC auditors
Team-NB meeting for the set up of a pool of auditors in the framework of the Code of conduct enforcement.
An article in Clinica by Ashley Yeo titled: As MDR vote nears, EU NBs show they mean business
The self-regulation of the EU’s notified bodies continues apace. On 4 September the European association that lobbies for the interests of NBs, Team-NB, will host a meeting that will aim to set up a board of auditors for EU NBs. This follows on from ...
Euransante
Euransante organized a conference sponsored by MEP Pargneaux at the European Parliament. Francoise Schemmer was invited to make a speech as Team-NB director.
QUESTIONS FORM on line.
QUESTIONS FORM on line.
Meeting in European Parliament in Strasbourg
under MEP, Holger Krahmer patronage in the framework of the adoptions of the new regulations.
Workshop in Frankfurt on ISO 62304
For more information http://www.vde.com/FAQ62304 and in our documents : FAQ IEC62304