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Team-NB approved a new Position Paper on the requirements for the EU MDR/IVDR Notified Body Partners under the Technical Cooperation Program on Exchange of Medical DeviceQuality Management System Regulation and ISO 13485 Audit Reports (TCP III) thanks to the preparation of the TCP task force members.

Team-NB Position Paper TCP V1

By | 2020-07-27T06:48:13+00:00 July 27th, 2020|news|0 Comments

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