FDA 2025 Credibility Infrastructure

Who We Serve

DeepCrispr is not a generic LLM evaluation tool. It is the credibility assessment infrastructure that biotech, pharma, and clinical AI teams need to meet the FDA's 2025 computational model requirements.

Biotech & Pharma Sponsors

IND / NDA / 510(k) Submissions

You deploy AI models in clinical development (drug-drug interaction checkers, dosing algorithms, imaging classifiers) but lack the credibility evidence the FDA now demands under the 2025 framework.

What DeepCrispr Delivers

  • Automated VVUQ scoring across Verification, Validation, and Uncertainty Quantification
  • Credibility Assessment Reports generated from real adversarial test results
  • Model Analysis Plan (MAP) artifacts ready for regulatory submission
  • Paper-cited evidence chains for every scored failure mode
See the VVUQ Assessment Battery

CROs & Regulatory Consultancies

Credibility Assessment Services

Your clients ask you to validate their AI/ML models for regulatory submissions, but current tools only measure accuracy on static benchmarks — they don't test real-world failure modes like hallucination, sycophancy, or tool bypass.

What DeepCrispr Delivers

  • White-label credibility infrastructure: run DeepCrispr's test battery against client models
  • 9 adversarial scenarios (T06-T14) covering DDI hallucination, billing upcoding, CRISPR fabrication
  • DeepEval integration: hallucination and tool-correctness scores powered by open-source LLM-as-judge
  • Export-ready regulatory artifacts: scored verdicts, context contradiction chains, ASME V&V 40 mapping
Contact Partnerships

Clinical AI / MLOps Teams

Model Monitoring & Governance

You build and deploy clinical decision support tools. Post-market, the FDA expects continuous monitoring — but your MLOps pipeline has no automated credibility checks.

What DeepCrispr Delivers

  • Continuous scoring endpoints: /score/hallucination, /score/tool-correctness, /score/abstention
  • In-memory caching + 30s timeout protection for production workloads
  • Graceful fallback: DeepEval LLM-as-judge when available, rule-based scoring always works
  • Health endpoint + artifact inventory for model registry integration
View Scoring API Docs

Regulatory Affairs & QA

FDA Compliance Evidence

The CORE-MD score, the AIM-NASH precedent, and the FDA's 7-step framework all require documented credibility evidence — but your teams produce it manually in spreadsheets and Word docs.

What DeepCrispr Delivers

  • Steps 4-7 of the FDA credibility framework automated with scored evidence
  • VCAS, VPES, MPES scoring aligned with CORE-MD consortium recommendations
  • Adversarial test artifacts with full provenance (prompt → response → verdict → paper citation)
  • Context of Use (COU) builder for risk-proportionate assessment scoping
See the Framework

Ready to Build Your Credibility Evidence?

Stop generating AI outputs without proof. Build the credibility assessment infrastructure the FDA demands.