Medical AI Services — Drop-in Section
Medical AI & Digital Health

FDA Strategy for Medical AI (SaMD) — Built for Clearance

We help AI-driven medtech and digital health teams choose the right FDA pathway (510(k), De Novo, PMA), design validation & real-world evidence, and harden cybersecurity & privacy programs.

Schedule Consultation See Services & Prices
Q-Sub / 510(k) / De Novo GMLP • Bias • Transparency Cybersecurity & Privacy Validation & RWE

Why Medical AI Is Different

Algorithms evolve, datasets drift, and regulators expect clarity on intended use, validation, transparency, and change control.

  • SaMD classification & intended use: align features with risk class & pathway.
  • Validation & RWE: dataset design, bias checks, transparent reporting, clinical utility.
  • Change control for AI/ML: PCCP / update protocols for learning systems.
  • Cybersecurity & privacy: FDA premarket expectations + HIPAA/FTC safeguards.

Medical AI Service Pillars

Clear deliverables, fixed-fee bands, and optional add-ons.

1

Regulatory Strategy & Pathways (SaMD)

$7,500–$18,000 strategy build • Prices page

SaMD classification, intended use, Q-Sub planning. 510(k)/De Novo/PMA positioning + PCCP/change-control concepts.

  • Classification & pathway decision memo
  • Q-Sub agenda + question set
  • Submission outline & key arguments
Book
2

Clinical & Data Strategy (GMLP-aligned)

$9,500–$25,000 evidence plan • Prices page

Evidence frameworks aligned to GMLP. Prospective/retrospective plans, performance targets, bias & transparency reporting.

  • Dataset design & partitioning plan
  • Stat plan + performance targets
  • Bias/robustness + transparency outline
Book
3

Cybersecurity & Privacy Readiness

$6,000–$16,000 premarket readiness • Prices page

Premarket cyber posture (SBOM, threat modeling, CVD) + privacy review for connected products and PHI handling.

  • Threat model + security requirements
  • SBOM guidance + vulnerability workflow
  • Privacy/data-flow + consent review
Book
4

Submission Build Support (Q-Sub / 510(k) / De Novo)

$18,000–$65,000 project-based • Prices page

Authoring, compilation, and submission management across the core sections, including validation narrative and lifecycle planning.

  • Section authoring + gap tracking
  • Labeling/IFU + risk alignment
  • Reviewer-ready responses & iterations
Book

Want a bundled quote (Pathway + Evidence + Cyber)? Book a triage call and we’ll price as a single scope.

Let’s De-Risk Your Medical AI

Tell us about your product and goals. We’ll propose a right-sized plan with clear milestones and fixed-fee or milestone billing.

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Charleston, SC • Serving clients nationwide & international