We prepare an FDA-ready, AI-specific Readiness & Deficiency Risk Audit package suitable for AI/ML-based Software as a Medical Device (SaMD), clinical decision support, or AI-enabled IVD software. This is structured exactly as FDA reviewers and internal audit teams expect to see it.
“We have an AI model — but we don’t know how to make it regulatory-approvable, clinically credible, reimbursable, and scalable.”
Purpose: Predict FDA deficiencies before submission.
Deliverables
- Line-by-line gap assessment vs:
- 21 CFR 820 / QMSR
- 21 CFR 814 / 807
- FDA AI/ML SaMD guidance
- IMDRF SaMD
- AI-specific deficiency heatmap
- “High-probability FDA questions” list
- Remediation plan with owners
Duration: 3–6 weeks