temp

registration

  • Assessment and execution of 510K and other submissions, assessments
  • Regulatory Strategy
  • Management / Leadership
  • Interface with Regulatory Agencies
  • Recalls & Complaint Analysis
  • quality
  • QMS Development & Ownership
  • Design Assurance
  • Risk Management
  • Post-market surveillance
  • Recalls & Complaint Analysis
  • Assess design changes to regulatory approach