We help hospitals, children’s hospitals, and medical device companies implement FDA-ready, HIPAA-compliant AI governance at 40-70% lower cost than Big Four consultancies.
Healthcare organizations face an impossible choice when deploying AI
6-12 months, $200K-$500K, generic frameworks, junior staff
Limited framework coverage, unproven methodologies, can't scale
Regulatory complexity, high risk of mistakes, no validated frameworks
Security-first AI governance, delivered by senior practitioners, at a fraction of traditional consulting costs.
We verify, test, and prove control. No vendor claims without validation.
AI drifts, models fail, vendors get compromised. We build governance that handles failure gracefully.
Audit-ready documentation, immutable logs, traceability. Governance that survives FDA inspection.
Clear approval paths, risk-based controls, fast-track processes. Governance accelerates deployment.
Every engagement led by senior principals - you get the expertise you're paying for, not junior staff ramping up on
your time.
Clinical AI, documentation, imaging, operations, and decision support—all under one security-hardened governance model. FDA medical device determination included.
Pediatric PHI, guardian consent, age-specific risk models, and high-stakes care require dedicated AI guardrails. We built a specialized Pediatric AI Safety Program for this.
AI-enabled devices, FDA submission readiness, model supply chains, and edge inference with security baked in. From design controls through post-market surveillance.
Become enterprise-ready with AI security and governance your customers can trust. HIPAA BAA-ready, audit-ready documentation, and customer-facing security architecture.
PHI-heavy analytics and LLM workflows governed, monitored, and defensible. Clinical decision support that satisfies regulatory and contractual obligations.
We founded MeridianAI after seeing the same pattern repeatedly: healthcare organizations deploying AI without the security and governance infrastructure it requires.
Hospitals had clinical AI running in production—sepsis prediction, imaging analysis, documentation—but no clear inventory of what AI existed, no PHI-aware controls, and no one who could definitively answer: “Is this FDA-regulated?”
Medical device companies were building AI-powered devices with brilliant clinical teams but lacked the governance and quality systems FDA expects. They’d discover this 18 months into development—too late to retrofit without massive delays.
The options available were all bad:
– Big Four consultancies charging $200K-$800K for 6-12 month generic AI governance programs
– Boutique firms with unproven methodologies and limited healthcare depth
– Go it alone and risk FDA enforcement, HIPAA violations, or worse—AI-driven patient harm
We built MeridianAI to change this.
We bring 20+ years of cybersecurity discipline specifically to healthcare AI governance. Not generic AI governance adapted for healthcare. Not compliance theater. Security-hardened, audit-ready, defensible governance.
We made a deliberate choice: healthcare only. Not financial services. Not manufacturing. Healthcare.
Why? Because healthcare AI governance requires depth:
– FDA medical device regulations (SaMD, MDDS, CDS)
– HIPAA privacy and security rules (PHI in training data, prompts, logs)
– Clinical safety standards (ISO 14971, IEC 62304)
– NIST AI RMF adapted for healthcare contexts
You can’t be an expert in healthcare AI governance and also do retail, finance, and manufacturing. We chose depth over breadth.
We work exclusively with healthcare organizations deploying AI. We deliver in weeks, not months. We charge 40-70% less than Big Four consultancies while maintaining senior-led, enterprise-grade quality.
If you’re a hospital, children’s hospital, medical device company, payer, or healthtech vendor deploying AI—and you need governance that’s secure, compliant, and defensible—we should talk.
MeridianAI is led by senior cybersecurity and compliance practitioners with:
– 20+ years implementing security programs in regulated industries
– CISSP and CISM certifications
– Deep healthcare regulatory expertise (FDA, HIPAA, NIST)
– Enterprise-scale program development experience
Every engagement is led by senior principals—you get the expertise you’re paying for, not junior staff learning on your project.
Security and governance should enable AI deployment, not smother it.
We don’t believe in compliance theater—creating policies that no one reads and controls that no one enforces. We build governance that’s:
– Technically defensible (not just policy documents)
– Audit-ready (survives FDA inspection and OCR investigation)
– Operationally practical (integrates with clinical workflows)
– Security-hardened (designed for failure, not perfection)
We assume risk is real. We don’t trust vendor claims, marketing materials, or default configurations. We verify, test, and prove control—the same discipline we bring to security architecture.
We design for failure. AI will drift. Models will fail. Vendors will be compromised. We build governance that expects and handles failure gracefully.
AI governance here requires depth:
You can’t master healthcare AI governance while serving finance, retail, and manufacturing. We chose depth over breadth.
We deliver in 4-10 weeks at 40-70% lower cost than Big Four consultancies. Every engagement led by senior principals—you get expertise, not junior staff.
| Factor | MeridianAI | Big Four | Boutique |
|---|---|---|---|
| Timeline | 4-10 weeks | 6-12 months | 8-16 weeks |
| Investment | $9.5K-$250K | $200K-$500K+ | $40K-$150K |
| Staffing | Senior principals | 60-80% junior | Small team |
| Focus | Healthcare-only | Multi-industry | Limited |
| Pricing | Transparent, fixed | Opaque, T&M | Varies |
We help you deploy AI safely and securely—without slowing innovation.
