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  • NBOG Documents
    In the light of NBOG’s terms of reference – to identify and promulgate examples of best practice to be adopted by both Notified Bodies and those organisations responsible for their designation and control – NBOG has produced the
  • NBOG - Start
    In July 2000, Member States and the European Commission agreed to set up the Notified Body Operations Group (NBOG) This was in response to widespread concern that the performance of Notified Bodies in the medical device
  • Guidance for manufacturers and Notified Bodies on reporting . . .
    NBOG’s Best Practice Guide 2014-3 NBOG BPG 2014-3 Page 4 of 19 Verification and validation performed by the manufacturer to take the decision to effectively modify the product or the product range or the quality system
  • NBOG_BPG_2010_1_Supplier_E
    NBOG’s Best Practice Guide 2010-1 NBOG BPG 2010-1 Page 3 of 7 1 Verify that procedures for conducting supplier evaluations have been established (ISO 13485:2003: 7 4 1) • Documented process product controls for
  • DESIGNATING AUTHORITIES HANDBOOK
    The Handbook has been produced by the Notified Body Operations Group (NBOG) It draws on a variety of guidance documents produced by various organisations as well as specific material produced by NBOG
  • NBOG Reports and News
    NBOG WD 2017-2 Draft list of codes and corresponding types of devices for the purpose of specifying the scope of the designation of notified bodies under the Regulation (EU) 2017 745 (MDR) Aug 2017
  • NBOG_BPG_2006_2
    NBOG’s Best Practice Guide applicable for AIMDD, MDD, and IVDD 2006-2 NBOG_BPG_2006_2 doc Page 1 of 30 Certificates issued by Notified Bodies with reference to Council Directives - 93 42 EEC on- 98 79
  • Microsoft Word - NBOG_BPG_2009_3. doc
    Any change of or addition to the scope expressions is subject to NBOG endorsement The scope expressions consider different requirements of different directives, technologies, use of the devices and the risks associated with the


















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