From ideation to market dominance

Fission Consulting accelerates your SaMD venture through expert consulting, ensuring seamless development, successful launch, and sustained excellence.

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Quality Assurance

  • Leadership and Strategy
    • Fractional Head of Quality and Regulatory Affairs
    • Staff Augmentation
  • Quality Systems
    • Gap Assessments and QMS improvement
    • QMS Development and Market Expansion
    • FDA 483 Remediation
    • On-site audit support
    • Internal Quality System Audits
    • Supplier Quality Audits
    • Supplier and Vendor Quality Oversight
    • 21 CFR Part 11 Assessment and Remediation

Design & Development

  • Design Project Planning
  • DHF Development
  • Design File Gap Analysis and Remediation
  • Risk Management
  • Design Transfer
  • Development Team Augmentation

    Regulatory

    • New product Regulatory Assessments
    • Expanding Indications for Use
    • Regulatory roadmap development and planning
    • Submissions
      • FDA Pre-submissions/Q-Sub Meetings
      • FDA Breakthrough Applications
      • FDA Small Business Designation
      • US FDA 510(k) Clearance
      • CE Mark
      • De Novo
      • PMA

    Clinical Affairs

    • Clinical Evaluation Reports
    • GCP Auditing and Study Site Oversight
    • Clinical Process and Protocol Development

      Marketing

      • Brand development
      • Strategic planning
      • Content strategy and content marketing
      • Social media management
      • Ad campaigns
      • Web development and optimization
      • Email marketing
      • Analytics and reporting

      Market Access Pillars

      01 pillar

      Design & Development
      • Project Management
      • Design History File Creation

       

      02 pillar

      Clinical Development

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      03 pillar

      Quality Systems & Compliance

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      04 pillar

      Regulatory Affairs

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      05 pillar

      Commercialization

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      06 pillar

      Maintenance

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