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.