Premarket Notification (510(k))
- Predicate device identification and substantial equivalence analysis.
- Full 510(k) USFDA submission preparation.
- Mandatory eSTAR template implementation.
- Performance testing data assembly.
- Labeling, User Manual, and instructions for use review, compliant with standards like ISO 15223.
Premarket Approval (PMA)
- Investigational Device Exemption (IDE) application.
- Clinical trial design and protocol development.
- Complete PMA application assembly.
- Clinical data analysis and presentation.
- Manufacturing facility information preparation.
De Novo Classification Requests
- Novel device classification strategy (FDA De Novo).
- Risk-benefit analysis documentation.
- Clinical and technical evidence assembly.
- Regulatory pathway justification.
Quality System Compliance
- Quality Management System implementation guidance.
- QMSR/ISO 13485 compliance support.
- Pre-audit preparation and gap analysis.
- Corrective and preventive action systems.
Post-Market Compliance
- Establishment registration and device listing.
- Unique Device Identification (UDI) implementation.
- Medical Device Reporting (MDR) compliance.
- Annual reporting and compliance maintenance.