Risk-based product classification
Regulatory submission type in the major global markets
Submission strategy and timeline
FDA Q-Submission Program
FDA Investigational Device Exemption (IDE)
FDA Premarket Applications (510k, De Novo, PMA)
Health Canada License Applications
CE Marking (IVDR, MDR)
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.