FDA & medical devices

FDALattice

FDA-regulated agents need design controls and validation. FDALattice brings 21 CFR Part 11 discipline to medical AI.

In the pipeline — products publishing now

The FDALattice store

Stocking up now: a 50-product roadmap is in production and new self-serve kits publish daily — 0 live products today. Start free below while the shelves fill.

How the FDALattice ecosystem runs

Three loops feed each other — content brings readers, readers become buyers, buyers climb the ladder.

📝 Content loop

FDA & medical devices explainers, checklists, and teardown playbooks — the FDA & medical devices library with no home until now.

🧲 Lead loop

FDA & medical devices teams find the content, grab the free playbook, and climb into the FDALattice product line.

🪜 Product loop

$19 starter kits climb to $29 tools and templates, $49 packs and decks, and $149 flagship kits.

Start here

Three free or cheap entry points — pick whichever fits.

1

Free MIT playbook

The ghostcorpnet playbook — free, MIT-licensed. Read it here →

2

The $5 AI Agent Risk Scan

A five-minute self-audit of your agent setup. Get the scan →

3

Browse the catalog

Every ghostcorpnet product in one filterable grid. Open the catalog →

Build on FDALattice

Every ecosystem follows the open ghostcorpnet Pack Standard v1 — interoperable packs, a public directory, and a certification badge.

Stores in FDALattice

50 specialized stores — each one a sub-niche of FDA & medical devices. New kits publish daily.

FDA Basics Store

FDA, explained.

1 in the pipeline

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510k Store

Clear the 510(k).

1 in the pipeline

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De Novo Store

Classify the novel device.

1 in the pipeline

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PMA Store

Approve the high-risk device.

1 in the pipeline

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eSTAR Store

Submit in eSTAR.

1 in the pipeline

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QMSR Store

Quality systems, current.

1 in the pipeline

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Design Controls Store

Design it right.

1 in the pipeline

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AI ML Devices Store

AI as a medical device.

1 in the pipeline

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PCCP Store

Plan the algorithm's evolution.

1 in the pipeline

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Part 11 Store

Electronic records, compliant.

1 in the pipeline

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Clinical Trials Store

Trial the device.

1 in the pipeline

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FDA Metrics Store

Measure the submissions.

1 in the pipeline

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FDA Audit Store

Assess before FDA.

1 in the pipeline

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FDA Prompts Store

AI-assisted regulatory work.

1 in the pipeline

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Submission Builder Store

Plan the submission.

1 in the pipeline

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FDA Training Deck Store

Train the team.

1 in the pipeline

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Labeling Store

Label it right.

1 in the pipeline

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Postmarket Store

Watch after launch.

1 in the pipeline

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FDA Inspection Store

Ready for investigators.

1 in the pipeline

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483 Response Store

Answer the 483.

1 in the pipeline

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SaMD Store

Regulate the software.

1 in the pipeline

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Cybersecurity FDA Store

Secure the device.

1 in the pipeline

Browse the store →

FDA for Startups Store

Regulatory on a budget.

1 in the pipeline

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Pre-Sub Store

Ask FDA first.

1 in the pipeline

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FDA Maturity Store

From prototype to approved.

1 in the pipeline

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FDA Audio Course Store

Learn FDA on the go.

1 in the pipeline

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FDA Template Vault Store

Everything, one download.

1 in the pipeline

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RAC Prep Store

Get credentialed.

1 in the pipeline

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AI FDA Copilot Store

An AI aide for regulatory.

1 in the pipeline

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Biocompatibility Store

Prove it's safe.

1 in the pipeline

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Sterilization Store

Validate sterility.

1 in the pipeline

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Software Validation Store

Validate the software.

1 in the pipeline

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Risk Management ISO Store

Manage device risk.

1 in the pipeline

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Usability Engineering Store

Design for safe use.

1 in the pipeline

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FDA Board Deck Store

Report regulatory upward.

1 in the pipeline

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Submission Tracker Store

Track every submission.

1 in the pipeline

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Combination Products Store

Regulate the combination.

1 in the pipeline

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Enterprise FDA Suite Store

Regulatory at global scale.

1 in the pipeline

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Pathway Selector Store

Find your pathway.

1 in the pipeline

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IVD Store

Regulate the diagnostic.

1 in the pipeline

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FDA Workshop Deck Store

Workshop the strategy.

1 in the pipeline

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Advertising Promo Store

Promote compliantly.

1 in the pipeline

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Import Export FDA Store

Move products across borders.

1 in the pipeline

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Digital Health Store

Navigate digital health.

1 in the pipeline

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FDA Myths Store

Truth about FDA.

1 in the pipeline

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FDA QMS Software Store

Digitize the QMS.

1 in the pipeline

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FDA Human Factors Store

Use-safety evidence.

1 in the pipeline

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FDA Real World Evidence Store

Evidence from practice.

1 in the pipeline

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FDA Breakthrough Store

Faster for breakthroughs.

1 in the pipeline

Browse the store →

FDA Export Certs Store

Sell globally.

1 in the pipeline

Browse the store →

Works with

Cluster: Legal & Compliance

FDALattice runs alongside its cluster siblings and plugs into related ecosystems across the ghostcorpnet constellation.

ActLattice

EU AI Act compliance

EU AI Act readiness for agent builders and deployers, step by step.

Explore →

LawWarden

Legal

Legal AI agents with privilege, confidentiality, and audit trails built in.

Explore →

SOC2Warden

SOC 2

SOC 2 evidence, collected by agents.

Explore →

FinLattice

Finance

Money-moving agents need money-grade controls. Here's the kit.

Explore →

SecWarden

AI agent security

Attack your agents before someone else does: injection tests, guardrails, and tamper-evident logs.

Explore →