Solutions · Medtech & Digital Health
AI Governance for FDA-Regulated Companies
One assessment maps your AI systems to FDA SaMD, ISO 14971, HIPAA, and NIST AI RMF — producing the evidence artifacts your regulatory team needs before an audit.
Who this is for
Built for teams shipping AI under FDA oversight
Medical Device Manufacturers
You are adding AI/ML functions to devices or building Software as a Medical Device. Your regulatory team needs AI-specific risk and validation evidence that fits alongside your existing design controls and risk management file.
Digital Health Platforms
You run AI in clinical workflows, remote monitoring, or patient-facing tools. You need to show how each AI system handles PHI, how it is monitored, and who is accountable when it gets something wrong.
Health-Tech AI Vendors
You sell AI into hospitals and health systems. Procurement and security reviews now ask for AI governance documentation — and a HIPAA attestation alone no longer answers the question.
Frameworks we cover
One assessment, six frameworks
FDA SaMD
Software as a Medical Device guidance for AI/ML-enabled functions
ISO 14971:2019
Risk management for medical devices, applied to AI/ML hazards
HIPAA
Security and Privacy Rule safeguards for AI systems handling PHI
NIST AI RMF
Govern, Map, Measure, and Manage functions for AI risk
EU AI Act
High-risk AI obligations for devices placed on the EU market
SOC 2
Trust Services Criteria for the platform and data around your AI
The pain we solve
Where AI governance breaks down in regulated health
FDA pre-submission AI documentation gaps
Pre-submission and marketing submission packages increasingly need a clear account of how AI/ML functions were developed, validated, and will be monitored. Most teams assemble that story by hand, late, and from scattered sources.
ISO 14971 risk management evidence for AI/ML
Your risk management file was built for deterministic software. AI/ML introduces hazards — data drift, bias, performance degradation — that need to be identified, controlled, and traced with the same rigor.
HIPAA AI system audit trail requirements
When AI systems touch PHI, you need to show who accessed what, when, and through which model. Without a consistent audit trail, an OCR inquiry or customer security review turns into a scramble.
See how Evolve Edge maps to FDA SaMD requirements
Walk through a sample assessment with our team and see the evidence artifacts your regulatory team would receive.