WHAT I DO...

I offer a variety of services to clients including

  • GLOBAL STRATEGY
    • Create global regulatory strategy
    • Determine device classifications
    • Select predicate (if applicable)
    • Propose Intended use / indications for use
    • Identify unique country requirements
    • Identify global clinical requirements
    • Identify potential risks and mitigations
  • REGULATORY SUBMISSIONS
    • Plan, write, format, edit, review
    • US: 510(k), PMA, IDE, Supplements, AR
    • EU: Technical Files and Design Dossiers
    • International submissions
    • Communicate with reviewers
    • Manage response strategy
    • Write and review responses
  • TECHNICAL DOCUMENTATION
    • Review protocols, reports and raw data
    • Design validation and verification
    • Shelf life and stability
    • Engineering and manufacturing documents
    • Pre-clinical and clinical studies
    • Biocompatibility
    • Sterilization
    • Review product labeling
    • Review advertising and promotional materials
  • PROJECT MANAGEMENT
    • Partner with development teams and management
    • Build submission schedules
    • Identify deliverables needed
    • Manage project submission timelines

GET IN TOUCH...

For inquiries or to arrange a consultation, send a message.