NBOG Publishes revised best practice guidance documents (Nov 2014)

bio_subbu

bio_subbu

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Dear All

The Notified Bodies Oversight Group (NBOG) has published (Nov. 2014) the following revised guidance documents in its series of best practice guidelines on specific aspects related to the activities of Notified Bodies.

To access the guidance documents, refer the below links;

1. NBOG BPG 2014-3 - Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System
2. NBOG BPG 2014-2 - Guidance on the Information Required for Notified Body Medical Device Personnel Involved in Conformity Assessment Activities
3. NBOG BPG 2014-1 - Renewal of EC Design-Examination and Type-Examination Certificates: Conformity assessment procedures and general rules

NBOG Forms;

4. NBOG F 2014-1 - Application form to be submitted when applying for designation as a notified body
5. NBOG F 2014-2 - Qualification of personnel (see NBOG BPG 2014-2)

Hope you will find useful…
 

Attachments

  • NBOG_BPG_2014_3.pdf
    306 KB · Views: 181
  • NBOG_BPG_2014_2.pdf
    174.7 KB · Views: 169
  • NBOG_BPG_2014_1.pdf
    178.5 KB · Views: 198
  • NBOG_F_2014_1.doc
    147.5 KB · Views: 115
  • NBOG_F_2014_2.doc
    423.5 KB · Views: 114
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