world wide medical device and IVD Classification

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we can classify your device according to all international legaslation including
  • Medical device Regulation
  • FDA
  • other international domains
Reclassification according to new regulations is also supported including preparation of reclassification frame work, protocol, and report.

we can support also in classification of border line devices

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  • Home
  • Services
    • Regulatory Affairs >
      • Classification
      • Registration
    • Training
    • Clinical Evaluation >
      • Clinical Evaluation
    • Translation
    • Technical file review
    • EUAR
    • FDA Services
    • Calibration
  • Contact