Real-timeVisibility
RequirementsLinked to Evidence
AutomatedAudit Readiness
Continuouscompliancemonitoring

Regulatory compliance shouldn't feel like a guessing game

Know exactly where your QMS stands. AI-powered visibility into how your QMS aligns with regulatory requirements, across every clause and every document.

Regulatory Status Center
Current StatusISO 13485 ▾
91.8%+3.7% this quarter
257 requirements analyzed
130 documents mapped
! 21 compliance gaps identified
! 4 high risk compliance gaps identifiedSee details ›
Updated 2 minutes ago

The QMS platform for the AI Era

AI-Powered Compliance Mapping

Your documents are mapped to regulatory frameworks automatically. No manual cross-referencing, no static spreadsheets, no guesswork. You get clear, document-linked compliance evidence that's always up to date.

  • Clause-by-Clause Mapping
  • Evidence Linked to Documents
  • Gap Identification
  • Audit-Ready at All Times
  • Changes Tracked Against Compliance
  • No Manual Cross-Referencing
Document with multiple compliance annotations highlighted

Audit-Proof Your QMS

Siloe maps your QMS directly to regulatory frameworks, replacing guesswork with precise evidence and gap analysis. We automate the tedious alignment process, so you can stop searching for gaps and start fixing them.

QMS classifications dashboard with expanded annotation evidence
Document editing with compliance confidence

Edit Documents With Confidence

Unlike other eQMS platforms that require downloading, editing externally, and re-uploading, Siloe lets you create, edit, review, and approve documents directly in-platform with full compliance visibility. No more worrying that a well-intentioned revision quietly removes coverage.

Compliance That Keeps Up With You

As your QMS evolves, Siloe's compliance mapping updates with it. Every revision, every new document, every approval. You always have a current view of where you stand, not a snapshot from the last time a review was performed.

QMS classifications showing absent annotation gaps

Compliance Without the Guesswork

See your QMS clearly, clause by clause and document by document, with all supporting evidence organized and accessible in one place.

Currently supporting ISO 13485, with EU MDR and 21 CFR 820 support coming soon.