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
  • U.S. traditional and special 510(k), De Novo Designation Request, Breakthrough Device Designation Request, Investigational Device Exemptions (IDE), Pre-Market Approval (PMA) and Emergency Use Authorizations (EUA)
  • European technical document and design dossier preparation
  • Preparation for Medical Device Regulation (EU MDR) implementation in Europe
  • FDA, Notified Body, and ISO 13485 registrar audit preparation and participation