• Medical Programs

Foto Medical Programs Medical Programs are being ranged under two categories that;

Medical Devices are various types of equipments, tools, devices, materials and other components which do not scatter pharmacological, immunological and metabolic effects to the human body in case of use, shall be monitored, taken under control, and are being used for treatment.
 
Medical Accessories are being evaluated as Medical Devices and Medical components in order for collocation.

  • System
  • Product
  • Inspection and Validation
  • Training
  • Inspection and Validation
    • a)     VALIDATION

      •     CLEAN ROOM
      •     STERILISATION
      •     DISINFECTION
      •     SOFTWARE
      •     OPERASYON PERFORMANS

      » DEVICE  INSTALLATION, OPERATION, PERFORMANCE

      •     WATER TERATMENT SYSTEMS AND RO
      •     FILLING
      •     PACKAGING

      b)            PRODUCTION/SERVICE AREA ASEPCY, HYGIENE AND SANITATION


      c)            SUPPLIER, RAWMATERIAL AND LOADING CONTROL
  • Training
      • REGULATORY, SYSTEM, PRODUCT AWARENESS, BASIC AND ADVANCED
      • INTERNAL - LEAD AUDITOR
      • ASEPCY,HYGIENE AND SANITATION
      • CLINICAL DATA EVALUATION
      • BIOMEDICAL CALIBRATION AND VERIFICATION / BIOCOMPATIBILITY
      • VIGILANCE
      • RISK MANAGEMENT
  • Product
      • CE MARKING (OEM,MDD)
  • System
      • QUALITY (ISO 9001, ISO 13485)
      • LABORATORY– HOSPITAL ACCREDITATION
      • GMP, GLP, GDP, GAMP, GTP, GRP, GCP
  • Categories

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