Call Now
+91-8806 065 922
Afra Pharma Consultant Logo
Mail Now

Medical Devices

We provide expert regulatory, clinical and compliance services to Pharmaceutical medical device manufacturers.

Our Services Include The Following:

  • Preparation and submission of Regulatory documentation including
  • Technical Files
  • Design Dossiers
  • Regulatory and Technical review and consulting
  • Preparation and submission of registration for product applications
  • Medical device vigilance and reporting systems
  • Regulatory and manufacturing compliance
  • Strategic and regulatory planning
  • Regulatory/Quality GAP Analysis
  • Interpretation of guidance documents and legislation
  • Assistance with device labeling requirements
  • Provide medical device classification