Regulatory Strategy

  • Risk-based product classification

  • Regulatory submission type in the major global markets

  • Submission strategy and timeline

  • Budget considerations

Working Together

Regulatory Submissions

  • FDA Q-Submission Program

  • FDA Investigational Device Exemption (IDE)

  • FDA Premarket Applications (510k, De Novo, PMA)

  • Health Canada License Applications

  • CE Marking (IVDR, MDR)


Quality Systems

  • Design, implementation and audit of quality management systems to comply with 21 CFR Part 820 (QSR) and ISO 13485.

  • Implementation of QSR in CLIA-licensed laboratories to support companion diagnostics (CDx) development.

  • Mock FDA Level II QSIT inspections.

  • Remediation of FDA Warning Letters and Notified Body audits.


FDA Consulting, LLC maintains nondisclosure agreements with a network of affiliated experts with product-specific expertise in market research, design, development, software, risk management and packaging validation who will contribute to your project's success.

Contact us to learn more.