Cindy, Author at Welcome to Team NB | Team NB

Members exclusive access

About Cindy

This author has not yet filled in any details.
So far Cindy has created 153 blog entries.

Team-NB members adopted a Position Paper for the interpretation of device related changes in relation to a Notified Body Opinion as required under Article117 of Medical Device Regulation (EU)2017/745.

Team-NB members adopted a Position Paper for the interpretation of device related changes in relation to a Notified Body Opinion as required under Article117 of Medical Device Regulation (EU)2017/745.

Team-NBPosition-Paper-Art117SubChangeLifeCycleMngt-202012

By Cindy| 2021-02-19T12:35:42+00:00 December 21st, 2020|news|0 Comments

Team-NB members adopted a Position paper on Directives expiring certificates – impacts and suggested solutions following a survey among NBs which took place in the automn.

Team-NB members adopted a Position paper on Directives expiring certificates – impacts and suggested solutions following a survey among NBs which took place in the automn.

Team-NB-PositionPaper-ExpiringCertificates-20201215

By Cindy| 2021-02-19T12:35:56+00:00 December 16th, 2020|news|0 Comments

The MDCG published a new guidance as MDCG 2020-17related to “Questions and Answers related to MDCG 2020-4”.

The MDCG published a new guidance as MDCG 2020-17related to “Questions and Answers related to MDCG 2020-4”.

MDCG-2020-17-guidance-Q-A

By Cindy| 2021-02-19T12:36:07+00:00 December 2nd, 2020|news|0 Comments

The Commission makes available a general forecast of upcoming meetings of MDCG and subgroups for 2021

The Commission makes available a general forecast of upcoming meetings of MDCG and subgroups for 2021

md_events_2021_26 Nov 2020

By Cindy| 2021-02-19T12:36:22+00:00 December 2nd, 2020|news|0 Comments

Team-NB adopted a Position Paper prepared by the Mirror IVD WG on Team-NB consideration paper on IVDR Date of Application

Team-NB adopted a Position Paper prepared by the Mirror IVD WG on Team-NB consideration paper on IVDR Date of Application

Team-NB-PositionPaper-Team-NB consideration paper on IVDR Date of Application

By Cindy| 2021-02-19T12:36:39+00:00 November 28th, 2020|news|0 Comments

Team-NB committee adopted a Position Paper on remote auditing experience following the results of a survey addressed to all Medical Devices Notified Bodies

Team-NB committee adopted a Position Paper on remote auditing experience following the results of a survey addressed to all Medical Devices Notified Bodies

Team-NB-PositionPaper-RemoteAudits-20201118

By Cindy| 2021-02-19T11:10:54+00:00 November 19th, 2020|news|0 Comments

Team-NB welcomed a 26th member, namely CE Certiso Kft. – Hungary, (Notified Body 2409)

Team-NB welcomed a 26th member, namely CE Certiso Kft. – Hungary, (Notified Body 2409)

By Cindy| 2020-11-06T23:54:40+00:00 November 6th, 2020|news|0 Comments

37 NBs answered to a survey doing their remote audit experience

37 NBs answered to a survey doing their remote audit experience

NBM-065-20 - Survey Remote Audits - Oct 2020V2.pdf

By Cindy| 2020-11-03T17:30:17+00:00 November 3rd, 2020|news|0 Comments

The EU granted CORE-MD project with ESC as sponsor and Team-NB as one of the partner.

The EU granted CORE-MD project with ESC as sponsor and Team-NB as one of the partner.

By Cindy| 2020-11-06T23:52:52+00:00 October 23rd, 2020|news|0 Comments

Extraordinary General Assembly of the association will take place remotely.

Extraordinary General Assembly of the association will take place remotely.

By Cindy| 2020-08-27T07:57:35+00:00 August 27th, 2020|news|0 Comments