Clinical & Regulatory

Aran Biomedical can provide a comprehensive regulatory compliance consulting service to its customers, including:

  • Strategy development and device classification
  • Predicate device selection
  • Clinical Scientific Literature Review
  • 510(k) Pre-market Notifications submission
  • CE Mark / Technical Files and Design dossiers
  • Canadian Medical Device Licensing
  • FDA Establishment Registration and Device Listing
  • International Registration
  • Regulatory Program Development
By | 2017-05-11T12:19:37+00:00 April 11th, 2017|Services|0 Comments

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