Cindy, Author at Welcome to Team NB | Team NB

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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

Cindy2022-04-08T18:19:31+01:00

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

Cindy2022-04-08T18:19:31+01:00

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

Cindy2022-04-08T18:19:37+01:00

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

Cindy2022-04-08T18:19:37+01:00

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

Cindy2022-04-08T18:19:37+01:00

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

Cindy2022-04-08T18:19:38+01:00

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)

Cindy2022-04-08T18:19:38+01:00

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

Cindy2022-04-08T18:19:39+01:00

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.

Cindy2022-04-08T18:19:39+01:00

Extraordinary General Assembly of the association will take place remotely.

Extraordinary General Assembly of the association will take place remotely.

Cindy2022-04-08T18:19:39+01:00