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Operon Strategist
Operon Strategist
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    • TURNKEY PROJECT CONSULTANTS
      • MEDICAL DEVICE MANUFACTURING FOR OMAN
      • PRODUCT FEASIBILITY & DETAIL PROJECT REPORT
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      • VALIDATION DOCUMENTATION
      • CLEAN ROOM GUIDANCE
      • QUALITY MANAGEMENT SYSTEM
        • FDA 21 CFR PART 820 QUALITY SYSTEM REGULATION
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      • DRUG DEVICE COMBINATION PRODUCTS
      • US FDA 21 CFR 820.30 DESIGN CONTROL REQUIREMENTS
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Operon Strategist
Operon Strategist
  • Home
  • SERVICES
  • REGULATORY APPROVALS
  • ABOUT US
  • CONTACT US
  • HOME
  • SERVICES
    • REGULATORY APPROVALS
      • CDSCO REGISTRATION in Oman
      • CE MARKING
      • DESIGN & DEVELOPMENT DOCUMENTATION
        • DRUG DEVICE COMBINATION PRODUCTS
        • US FDA 21 CFR 820.30 DESIGN CONTROL REQUIREMENTS
      • FDA 510 (K)
      • Oman Medical Device Registration
      • SFDA APPROVAL
      • UKCA Marking
    • TURNKEY PROJECT CONSULTANTS
      • CLEAN ROOM GUIDANCE
      • MANUFACTURING FACILITY
      • Medical Device Manufacturing for Oman
      • PRODUCT FEASIBILITY & DETAIL PROJECT REPORT
      • QUALITY MANAGEMENT SYSTEM
        • FDA 21 CFR PART 820 QUALITY SYSTEM REGULATION
        • ISO 13485 – QMS MEDICAL DEVICE
        • ISO 15378 CERTIFICATION | PRIMARY PACKGING REGULATORY CONSULTING
        • MDSAP
      • VALIDATION DOCUMENTATION
  • TESTIMONIALS
  • استشاريو مشاريع الأجهزة الطبية في عمان

Operon Strategist is a medical device regulatory consulting company which provides regulatory advisory & guidance to various manufacturers in the Oman to ensure the strategic development of these manufacturers.

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  • Regulatory Approvals
    • FDA 510(K)
    • CDSCO Registration
    • CE Marking
  • Turnkey Project Consultants
    • Clean Room Guidance
    • Manufacturing Facility
    • More Services

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