Capabilities

M.A.Fidar believes three basic principles for best-quality medical device production are research and development, accuracy in production, and quality management. As a result, all our efforts are aimed at fulfilling these three principles.

R&D Capabilities:

  • Complete Medical Device Development process from ideation to production
  • Benefiting from specialists in the production of medical equipment with specialties in medical engineering, mechanical engineering, construction and production engineering, polymer engineering, and metallurgical engineering
  • Computational Modeling and Simulation
  • Prototype Manufacturing
  • R&D, Pilot and Clinical study build
  • Process Verification and Validation

 

Production Capabilities:

  • 10K cleanrooms (700 square meters)
  • 100K cleanrooms (800 square meters)
  • Plastic Injection molding Unit
  • Medical Precision tube Extrusion Line
  • 000 Liters ETO sterilization Unit
  • Full coronary Balloon Catheter production line

 

Quality Control Capabilities:

  • Quality Assurance System certified and correspondent with ISO-13485 & GMP standard
  • Full equipped Microbiological Laboratories
  • Full equipped Mechanical Test Laboratories