Regulatory Pathway Orientation
- Device classification
- Predicate device exploration
- High-level 510(k) strategy outline
FDA & Regulatory Support
AvAm Global Med provides structured FDA support for small and emerging manufacturers entering the U.S. market. We focus on clarity, documentation, and U.S. Agent responsibilities.
510(k) & Documentation Support
- Technical file organization
- Software documentation guidance
- Risk management structure
- Submission preparation support (without claiming legacy expertise)
U.S. Agent Services
- Official FDA point of contact
- Communication relay and documentation handling
- Annual registration coordination
Basic Compliance & Labeling
- Label and IFU review
- Simple QMS alignment suggestions
- Documentation clarity and formatting support