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Get the expert advice on regulatory requirements
during FIME 2023

  • CE Certification as per MDR or IVDR
  • Getting USFDA 510(k) Approval
  • Gap Analysis (MDD to MDR, IVDD to IVDR)
  • NIOSH Certification
  • Updation or Preparation of Clinical Evaluation
  • EUDAMED Registration
  • Liability Insurance
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