Medical Device and In Vitro Diagnostics Medical Device Classification Assessment

The development of a sound device classification assessment and rationale is an essential starting point for medical device and IVD manufacturers and/or sponsors.

Our device classification will:

  • Research the device classification in accordance with the regulations for the nominated region(s).
  • Identify the classification rules which apply to your device(s) based on the manufacturers intended use.
  • Consider specific guidance documents issued by regulators, notified bodies, competent authorities etc.
  • Provide your organisation with the medical device and/or IVD medical device regulatory classification rationale.

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