At Mittal Consulting, we navigate your medical device through regulatory complexities for a seamless market entry. Collaborating closely, we find the optimal submission pathway, considering time, cost, and future benefits. Our expertise covers diverse regulatory submissions, including:

  • 510(k)s: Tailored for Class II devices in the U.S.
  • DeNovo Submissions: Facilitating entry for novel devices.
  • Pre-Submissions (Q-Submission): Strategic engagement with regulatory agencies.
  • PMAs: Guiding through the rigorous process for Class III devices in the U.S.
  • EU MDR Submissions: Ensuring compliance with updated EU regulations.
  • Health Canada MDL: Navigating the Canadian regulatory landscape.
  • Conformity Assessments (TGA): Meeting Australian regulatory requirements.
  • INMETRO Certification: Ensuring compliance with Brazilian standards.
  • ANVISA Technical Dossier Application Forms: Facilitating approvals in Brazil.