Services

Regulatory Strategy

• Risk-based product classification

• Regulatory submission type in the major global markets

• Submission strategy and timeline

• Budget considerations

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.