Regulatory & Submissions

MRC Global uses their consultant’s comprehensive knowledge of the regulatory submissions process to create and present submissions for approval and provide solutions for your regulatory needs. MRC Global Regulatory capabilities include:
  • Global Regulatory assessment, planning and strategy
  • Pre-submissions
  • Traditional and special 510(k)
  • Emergency Use Authorization (EUA)
  • Investigational Device Exemption (IDE)
  • Pre-Market Approval (PMA)
  • De novo preparation and submission
  • European technical file and design dossier preparation