We, Rescisco Global Regulatory consultants, intended to offer quality and regulatory services to the manufacturers of medical devices including in-vitro diagnostic medical devices from conceptualization stage to marketing as per the requirements.

Rescisco Global Regulatory Consultants > About Us > What We Do

What we do

  1. Designing of facility / Layouts
  2. Facility qualification
  3. Statutory clearances/ approvals
  4. Gap analysis
  5. Regulatory Strategy /pathway
  6. Documentation
  7. Technical file preparation
  8. Regulatory submissions
  9. Internal audits /regulatory audits
  10. Trainings
  11. Product registrations and licensing
  12. Consulting
  13. QMS planning
  14. Regulatory intelligence
  15. Market analysis/ strategy
  16. Human resource
  17. Authorized representative
  18. UK responsible person
  19. EU authorized representative
  20. US agent
  21. Vigilance/ Materiovigilance
  22. Medical writing/ Scientific Writing
  23. Labeling & Metrological certification
  24. Waste disposal registrations
  25. Export registration
  26. Testing of medical devices
  27. Risk assessment
  28. Clinical evaluation of medical devices
  29. Bio compatibility testing
  30. Sterilization (Gamma & Ethylene oxide)
  31. Handling of Non conformities