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Operon Strategist
  • Home
  • SERVICES
  • REGULATORY APPROVALS
  • ABOUT US
  • CONTACT US
  • HOME
  • Newsletter
  • SERVICES
    • REGULATORY APPROVALS
      • CDSCO Registration
      • CE Mark
      • DESIGN AND DEVELOPMENT DOCUMENTATION
        • DRUG DEVICE COMBINATION PRODUCT
        • US FDA 21CFR 820.30 DESIGN CONTROL REQUIRMENTS
      • EDA Registration
      • FDA 510k
      • SFDA Medical Device Registration
      • UK CA Marking
    • Turnkey Project Consultants
      • Clean Room Design
      • Manufacturing Facility
      • Product Feasibility & Detail Project Report
      • QUALITY MANAGEMENT SYSTEM
        • FDA 21 CFR part 820 Quality System Regulations
        • ISO 13485 certification
        • ISO 15378 Consultant
        • MDSAP
      • VALIDATION DOCUMENTATION
  • TESTIMONIALS
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Operon Strategist is a medical device regulatory consulting company which provides regulatory advisory & guidance to various manufacturers in the Egypt to ensure the strategic development of these manufacturers.

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    • EDA Registration
    • FDA 510(K)
    • CDSCO Registration
    • CE Marking
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    • Clean Room Guidance
    • Manufacturing Facility
    • Quality Management System
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