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Operon Strategist
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    • TURNKEY PROJECT CONSULTANTS
      • PRODUCT FEASIBILITY & DETAIL PROJECT REPORT
      • MANUFACTURING FACILITY
      • VALIDATION DOCUMENTATION
      • CLEAN ROOM GUIDANCE
      • MDSAP – Medical Device Single Audit Program
      • QUALITY MANAGEMENT SYSTEM
        • FDA 21 CFR PART 820 QUALITY SYSTEM REGULATION
        • ISO 13485 – QMS MEDICAL DEVICE
        • ISO 15378 CERTIFICATION | PRIMARY PACKAGING REGULATORY CONSULTING
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      • MEDICAL DEVICE REGISTRATION IN COSTA RICA
      • FDA 510 (K)
      • CDSCO REGISTRATION
      • CE MARKING
      • SFDA APPROVAL
      • UKCA Marking
    • DESIGN & DEVELOPMENT DOCUMENTATION
      • DRUG DEVICE COMBINATION PRODUCTS
      • US FDA 21 CFR 820.30 DESIGN CONTROL REQUIREMENTS
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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
        • US FDA 21 CFR 820.30 DESIGN CONTROL REQUIREMENTS
      • FDA 510 (K)
      • MEDICAL DEVICE REGISTRATION IN COSTA RICA
      • SFDA APPROVAL
      • UKCA Marking
    • TURNKEY PROJECT CONSULTANTS
      • CLEAN ROOM GUIDANCE
      • FDA 21 CFR PART 820 QUALITY SYSTEM REGULATION
      • ISO 13485 – QMS MEDICAL DEVICE
      • ISO 15378 CERTIFICATION | PRIMARY PACKAGING REGULATORY CONSULTING
      • MANUFACTURING FACILITY
      • MDSAP
      • PRODUCT FEASIBILITY & DETAIL PROJECT REPORT
      • QUALITY MANAGEMENT SYSTEM
      • VALIDATION DOCUMENTATION
  • TESTIMONIALS
Operon Strategist is a medical device regulatory consulting company that provides regulatory advice and guidance to various manufacturers in Costa Rica to ensure the strategic development of these manufacturers.

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  • Regulatory Approvals
  • Medical Device Registration in Costa Rica
    • FDA 510(K)
    • CDSCO Registration
    • CE Marking
  • Turnkey Project Consultants
    • Clean Room Guidance
    • Manufacturing Facility
    • Quality Management System
  • More Services

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