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So far PascalePerspectives has created 96 blog entries.

In the framework of the new Medical Device Regulations,

you will find below the Team-NB members’ intention to submit their application to be designated against MDR and/or IVDR. The Team-NB notified body members have a double advantage to pass their designation audit :   The peer review against the Code of Conduct which requirements are ahead of the today ones. The working groups reviewing [...]

By | 2018-06-29T11:19:19+00:00 July 18th, 2016|news|0 Comments

Negotiations

between the European Parliament on the future legislation are currently taking place. In this context, TEAM-NB, wishes to highlight several points still to be discussed between the Parliament and the Council. Enclosed our Position Paper on this negotiations.    

By | 2018-06-29T11:19:33+00:00 September 4th, 2015|news|0 Comments

Scrip Regulatory Affairs “Two EU notified bodies join international pilot to test common submission format for devices”

2 Notified bodies joined a pilot program that is being run by the International Medical Device Regulators Forum to test a common electronic submission format for reviewing device submissions.        

By | 2018-06-29T11:19:34+00:00 August 8th, 2015|Uncategorised|0 Comments