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Vira Andisheh Pad
  • Home
  • About
    • Vira Andisheh Pad
    • Our Supply Chain
  • Services
    • Supplying Medical Devices
    • Upgrading medical device manufacturers
    • Specialized training in field of medical devices
  • News
  • Contact
  • English

Tag: CE mark

February 8, 2020CE Marknews_admin

Which EU Notified Bodies Have Been “Designated” Under the MDR 2017/745 and IVDR (2017/746)?

Last update Feb 6, 2020 With the MDR deadline quickly approaching , many medical device manufacturers still don’t know for certain whether their Notified Body will be designated and when! A handful of large Notified Bodies (NB) have been approved, but for the others we can only guess when (or if) their designation will happen. […]

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October 12, 2019CE Marknews_admin

Medical device safety: IMQ has been appointed as the notified body for the new European Regulation

The notification, that was published on the 20th of August in the European NANDO system, allows IMQ to support right now medical device manufacturers in getting certification under the new MDR Regulation. The MDR – which will become mandatory as of the 26thof May and will replace the old Directives (93/42/EEC and 90/385/EEC) – is […]

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2017/745 CE mark conformity assessment Eurasia export IMQ irna ISO/TR 24971 ISO 13485 ISO 14971 IVDR MDR Medical Devices NANDO Notified Bodies Risk Management standards supply chain Trade

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