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

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

Useful Links

  • About Us
  • Contact Us
  • Testimonials
  • Careers
  • Upcoming Events and Expos
  • FAQ
  • Newsletter
  • Privacy Policy

Office Address

WhatsApp us

Mail Us: enquiry@operonstrategist.com