Regulatory Affairs for Medical Devices – EU MDR and IVDR
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Regulatory Affairs for Medical Devices – EU MDR and IVDR

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Regulatory Affairs Assitant – Elly

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What are the main Use-Cases of Elly:

  • Up to date on Regulations and Guidelines of 35+ Countries
  • Communicate with 1000’s of regulatory-related documents
  • Create Initial Regulatory Assessments with One Click
  • Get Assistance in creating the Intended Purpose
  • Get Assistance in classifying the product under EU MDR/IVDR and FDA

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IT INCLUDES: Complete MDR, Complete IVDR, New published EU documents, MDR / IVDR implementation guide

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