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Medical Device Regulatory Consultant
Operon Strategist
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    • TURNKEY PROJECT CONSULTANTS
      • Product Feasibility and Detailed Project Report
      • MANUFACTURING FACILITY
      • VALIDATION DOCUMENTATION
      • CLEAN ROOM GUIDANCE
      • QUALITY MANAGEMENT SYSTEM
        • FDA 21 CFR PART 820 QUALITY SYSTEM REGULATION
        • ISO 13485 – QMS MEDICAL DEVICE
        • ISO 15378 CERTIFICATION | PRIMARY PACKGING REGULATORY CONSULTING
    • REGULATORY APPROVALS
      • South African Health Products Regulatory Authority (SAHPRA)
      • FDA 510 (k)
      • CDSCO REGISTRATION
      • CE MARKING
      • SFDA APPROVAL
      • UKCA Marking
      • MDSAP
    • DESIGN & DEVELOPMENT DOCUMENTATION
      • DRUG DEVICE COMBINATION PRODUCTS
      • US FDA 21 CFR 820.30 DESIGN CONTROL REQUIREMENTS
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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 and Detailed 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
  • Home
  • SERVICES

Services

WHAT WE OFFER

turnkey project consultant

Turnkey Project Consultants

  • 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

  • South African Health Products Regulatory Authority (SAHPRA)
  • 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

CONTACT US TODAY

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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