Medical AI
Typical professional fees for regulatory, clinical/data, and services supporting AI/ML devices and SaMD. Project quotes vary by risk class, data complexity, and evidence requirements.
Transparent Pricing • Fixed-Fee Options
Regulatory Strategy & Pathways
SaMD / IVD Classification & Intended Use
$2,500–$6,000 scoping + memo
- Risk class & special controls mapping
- Indications/claims framing & labeling inputs
- Regulatory lane (510(k) / De Novo / PMA) recommendation
SaMDIVDCDS
Q-Sub (Pre-Sub) Questions & Package
$4,000–$8,500
- FDA-focused questions and briefing package
- Meeting prep & advisory; response strategy
Q-SubRTA/AI-ML
510(k) Strategy & Assembly
$18,000–$45,000
- Predicate & test plan alignment (eSTAR included)
- Submission authoring, review cycles & responses
Class IIeSTAR
De Novo Strategy & Dossier Outline
$12,000–$35,000
- Benefit-risk & special controls proposal
- Validation & real-world evidence plan
Novel AI/MLTPLC
PCCP (AI/ML Change Control Plan)
$6,000–$15,000
- Model update protocol, guardrails & metrics
- Transparency & documentation package
GMLPLifecycle
Labeling & Indications Drafting
$2,000–$6,000
- Intended use language & human-factors inputs
- Automation bias mitigations & disclosures
CDSHFE/UX
Clinical & Data Strategy
Evidence Plan (AI/ML & RWE)
$6,000–$18,000
- Dataset design, endpoints & statistical targets
- Bias analysis & transparency reporting
Prospective/RetrospectiveRWE
Performance Validation Protocols
$4,500–$14,000
- Partitioning, cross-validation & failure mode analysis
- Traceability & reproducibility package
VerificationValidation
Popular Bundles
AI SaMD Starter
$12,000–$24,000
- Classification & intended use, Q-Sub package, labeling draft
- Evidence plan (incl. bias & transparency) + PCCP outline
Fast-Track
510(k) Readiness
$28,000–$58,000
- Strategy + validation protocols + eSTAR assembly
- Cyber/Privacy review & response cycle support
Class IIeSTAR
Government, lab, and drawing/vendor fees are not included. Fixed quotes available after scoping. Pricing reflects typical market ranges for AI/ML medtech and SaMD projects of moderate complexity.