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Operon Strategist
Operon Strategist
  • Home
  • SERVICES
  • ABOUT US
  • Blog
  • 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

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WHAT WE OFFER

turnkey project consultant

Turnkey Project Consultants

  • Medical Device Manufacturing for Oman
  • Product Feasibility & Detail Project Report
  • Manufacturing Facility
  • Validation Documentation
  • Clean Room Guidance
  • Quality Managment System
  • FDA 21 CFR Part 820 Quality System Regulation
  • ISO 13485 - QMS Medical Device
  • ISO 15378 Certification | Primary Packaging Regulatory Consulting
  • MDSAP
regulatory consultant

Regulatory Approvals

  • Medical Device Regulations in Oman
  • FDA 510(k)
  • CDSCO Registration
  • CE Marking
  • SFDA
  • UK CA
  • Design & Development Documentation
  • Drug Device Combination Products
  • US FDA 21 CFR 820.30 Design Control Requirements

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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.

Services

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