Enterprise Governance

FDA 21 CFR & EU MDR Compliance

Built for Accuracy, Trust, and Regulated Content

SatelliteAI is designed for teams where accuracy matters -- from fast-moving marketing organizations to highly regulated industries. Our governance, verification, and audit capabilities support regulated content workflows without slowing down operations, with more than 99,000 SEO checks processed on the platform. Enterprise governance for answer engine optimization.

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Accurate before it ships Traceable after it ships Auditable when it matters Governed at scale

Why Compliance Now Matters for Search and Content

AI-era search changes the risk profile of published content. When answer systems summarize and cite content directly, a single unverified claim can create significant exposure.

That is why SatelliteAI pairs SEO and AEO optimization with verification-first governance.

  • Amplification risk -- claims repeated across multiple AI interfaces
  • Context loss -- content cited without original caveats
  • Brand and legal risk -- unverified claims create exposure
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Verification-First Governance

Content is verified before it ships, traceable after it ships, and auditable when regulators or quality teams require evidence.

Pre-publish verification
Source traceability
Full audit trails
E-signature support
U.S. FDA

Code of Federal Regulations Title 21

Regulated organizations often need controls that support labeling, claims, record integrity, and controlled processes.

21 CFR Part 801: Device Labeling

Claims and labeling routed through approval workflows. Page-level edits tracked with version history. Claim validation logic to reduce over-claiming.

21 CFR Part 809: In Vitro Diagnostics

Structured claims libraries and controlled language. Review workflows to reduce statement drift. Audit-ready traceability of changes and approvals.

21 CFR Part 812: Investigational Devices

Permission-based publishing controls. Review gates preventing unauthorized promotion. Audit logs for regulated content changes.

21 CFR Part 820: Quality System

Repeatable, controlled content workflows. Audit trails for inspection-style traceability. Governance aligned with process control expectations.

FDA 21 CFR Part 11 compatible audit trails and EU MDR compliance controls make SatelliteAI the only AEO platform built for regulated industries.

21 CFR Part 11

Electronic Records and Electronic Signatures

21 CFR Part 11 addresses criteria under which FDA considers electronic records and electronic signatures trustworthy, reliable, and equivalent to paper records.

Part 11-Aligned Controls

Trustworthy, reliable, equivalent to paper records and handwritten signatures, with FDA 21 CFR Part 11 compatible audit trails for approvals and record integrity.

  • E-signature support for approvals
  • Immutable audit trails
  • Role-based access controls
  • Versioning and record retention

EU MDR Considerations

Medical Device Regulation (EU) 2017/745 requirements for safety, performance, and labeling -- supported across 23+ languages with 93-96% translation quality scores in measured localization workflows.

  • Technical documentation tracking
  • Lifecycle maintenance workflows
  • Post-market surveillance support
  • Change control and traceability
Capabilities

Governance, Verification, and Audit Readiness

SatelliteAI's compliance-ready posture is built on three layers that work together to support regulated content workflows.

Governance

Controls to manage how content is created, reviewed, and published. Five-tier RBAC (Admin, Editor, Approver, Schema Approver, Company Admin), structured review stages, publish gates, and controlled change management.

Verification

Controls to reduce incorrect or unverifiable content. Claim validation logic, evidence grounding, source traceability, and verification-first reasoning via ODIN -- associated with about 90% hallucination reduction across 372 tests.

Auditability

Controls to reconstruct what happened, when, and by whom. Full audit trails, version history, change diffs, and e-signature support for approval events.

Verification-first governance means content is accurate before it ships, traceable after it ships, and auditable when regulators require evidence.

FAQ

Compliance Questions

SatelliteAI supports Part 11-aligned controls such as audit trails, e-signatures, and role-based access. Part 11 compliance depends on your organization's validation approach and specific predicate rule requirements.
No. SatelliteAI is designed to integrate into your existing quality and regulatory processes by supporting controlled workflows, traceability, and approval evidence.
SatelliteAI supports governed content creation, traceability, and change control that align with MDR expectations for lifecycle documentation maintenance and post-market surveillance artifacts.
SatelliteAI serves teams where accuracy matters -- from life sciences and medical devices to financial services and any organization where content claims carry regulatory or brand risk. Our governance features scale from fast-moving marketing teams to highly regulated enterprise environments.

Compliance Is
Operational Discipline

SatelliteAI helps teams maintain that discipline while adapting to AI-era search, where content is increasingly summarized, cited, and reused outside of its original context.

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Accuracy, traceability, and governance are now part of search visibility.