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Operon Strategist
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logo-operon-website
Operon Strategist
  • Home
  • SERVICES
  • REGULATORY APPROVALS
  • ABOUT US
  • CONTACT US
  • HOME
  • SERVICES
    • REGULATORY APPROVALS
      • CDSCO REGISTRATION
      • CE MARKING
      • DESIGN & DEVELOPMENT DOCUMENTATION
      • DRUG DEVICE COMBINATION PRODUCTS
      • FDA 510 (K)
      • SFDA APPROVAL
      • UKCA MARKING
      • US FDA 21 CFR 820.30 DESIGN CONTROL REQUIREMENTS
    • TURNKEY PROJECT CONSULTANTS
      • CLEAN ROOM GUIDANCE
      • MANUFACTURING FACILITY
      • MDSAP
      • 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
      • VALIDATION DOCUMENTATION
  • TESTIMONIALS

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

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