Quality System & Compliance
- FDA QSR (21 CFR Part 820) / ISO 13485 gap assessment
- Design controls review and documentation support
- Establishment registration and device listing (21 CFR Part 807)
- UDI system compliance review
- Post-market surveillance plan development
- Post-approval study (PAS) design for PMA holders
- MDR (Medical Device Reporting) advisory: reportability determinations and 21 CFR Part 803 obligations