Guidance for manufacturers and Notified Bodies on ...
dossier or the type examination dossier Document assessment related to the quality system, special audit or complete re-assessment of the quality system Update of the EC certificate or addenda if needed List of elements for which implementation has to be checked during the next audit
Download Guidance for manufacturers and Notified Bodies on ...
Information
Domain:
Source:
Link to this page:
Documents from same domain
Guidance on Design-Dossier Examination and …
www.doks.nbog.euNBOG’s Best Practice Guide 2009-1 NBOG BPG 2009-1 Page 2 of 6 3.3 The NB should review the manufacturer’s use of harmonised standards. If other standards have been used in place of harmonised standards or where harmonised standards do not
NBOG’s Best Practice Guide AIMDD, 2010-3
www.doks.nbog.euNBOG’s Best Practice Guide applicable for AIMDD, MDD, and IVDD 2010-3 NBOG BPG 2010-3 Page 1 of 35 Certificates issued by Notified Bodies with reference to
Guidance on Notified Body‘s Tasks of Technical ...
www.doks.nbog.euNBOG’s Best Practice Guide applicable for AIMDD, ⌧ MDD, and IVDD 2009-4 NBOG BPG 2009-4 Page 1 of 5 Guidance on Notified Body‘s Tasks of Technical Documentation Assessment on a Representative Basis
Designation and notification of conformity …
www.doks.nbog.euNBOG’s Best Practice Guide applicable for MDR, and IVDR 2017-1 NBOG BPG 2017-1 rev. 1 Page 1 of 16 Designation and notification of conformity assessment bodies
Guidance for Notified Bodies auditing suppliers to …
www.doks.nbog.euNBOG’s Best Practice Guide applicable for AIMDD, MDD, and IVDD 2010-1 NBOG BPG 2010-1 Page 1 of 7 Guidance for Notified Bodies auditing suppliers
Change of Notified Body - NBOG
www.doks.nbog.euNBOG’s Best Practice Guide applicable for AIMDD, MDD, and IVDD 2006-1 NBOG_BPG_2006_1.doc Page 1 of 4 Change of Notified Body Introduction
Guideline for Designating Authorities to Define the ...
www.doks.nbog.euNotification Scope of a Notified Body Conducting Medical Devices Assessments 1 Introduction NANDO [1], published and maintained by the European Commission, is an electronic register that enables interested parties to consult regulatory information of Notified Bodies (NBs). The