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Medical Device Regulatory Consultant
Operon Strategist
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      • QUALITY MANAGEMENT SYSTEM
        • FDA 21 CFR PART 820 QUALITY SYSTEM REGULATION
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Email
Medical Device Regulatory Consultant
Operon Strategist
  • ABOUT US
  • Blog
  • CONTACT US
  • HOME
  • SERVICES
    • REGULATORY APPROVALS
      • CDSCO REGISTRATION
      • CE MARKING
      • DESIGN & DEVELOPMENT DOCUMENTATION
      • DRUG DEVICE COMBINATION PRODUCTS
      • FDA 510 (k)
      • SFDA APPROVAL
      • South African Health Products Regulatory Authority (SAHPRA)
      • 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 – Medical Device QMS Services For South Africa
        • ISO 15378 CERTIFICATION | PRIMARY PACKGING REGULATORY CONSULTING
      • VALIDATION DOCUMENTATION
  • TESTIMONIALS
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  • REGULATORY APPROVALS
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Operon Strategist is a medical device regulatory consulting company that provides regulatory advice and guidance to various manufacturers in South Africa to ensure the strategic development of these manufacturers.

Services

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

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Mail Us: enquiry@operonstrategist.com