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Regulatory support for 510K and CE mark process for a new laboratory standard

  • Regulatory services - CMC writing - medical writing, Consulting - strategy and development
  • Human Medicines, Biopharmaceuticals, Medical Devices
  • Europe, North America
  • 04/07/2012


We need support to identify the requirements each of the sites involved in the manufacture, release and distribution of the standard must comply with for the step they are involved in the process.
Later we may also need advice on the documentation required to support the CE mark and 510K.


  • Experience in IVD regulation and scientific requirements for an IVD data package

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