AI-Powered Compliance for Healthtech—and Beyond
Automate audits, SOPs, and compliance checks. Stay 100% audit-ready across HIPAA, ISO 13485, ICH GCP, MDR, and 20+ global standards.
Audit Readiness Score
3 items need attention
Document Workflows
Regulatory Trackers
QMS Metrics
Automated SOP Coverage
AI Risk Flags Detected
Policy Reviews Due
Turn Compliance Into a Competitive Advantage
Fignos gives you the speed, visibility, and control to reduce risk and scale with confidence — all while cutting compliance costs by up to 60%.
Compliance Foundation
Bring structure, traceability, and regulatory control to your core documents and risk workflows.
Document Hub
QMS-backed document workflows
Organize, version, and trace compliance-critical files — with full approval history and checklist linking.
Learn MoreReadiness Engine
Supports HIPAA, 510(k), GMLP frameworks
Auto-generate checklists, validate evidence, and calculate real-time readiness scores.
Learn MoreCAPA Manager
ISO 14971 & 13485 compliant
Log, assign, and resolve risks with intelligent traceability across audits and teams.
Learn MoreAutomation & Intelligence
Track regulation changes, generate documentation, and validate AI models — all with audit-grade automation.
Document Builder
Built with FDA audit trails in mind
Create SOPs, consents, and protocols with templates structured for compliance.
Learn MoreRegulation Monitor
Real-time updates from FDA, ISO, HIPAA
Track clause-level changes, auto-flag impacted documents, and trigger checklist regeneration.
Learn MoreAI Trust Lens
GMLP, WHO, NIST RMF aligned
Validate AI/ML models for bias, fairness, and audit readiness — export trusted evidence.
Learn MoreExecution & Proof
Train your team. Submit with confidence. Prove you're audit-ready across every touchpoint.
Compliance IQ
SOP acknowledgment meets understanding validation
Validate what users know, not just what they read. AI tracks understanding inside your compliance flows.
Learn MoreDossier Builder
Submission-ready 510(k), IRB, or investor packages
Compile and export audit-grade submissions auto-linked to evidence and readiness scoring.
Learn More🏛️ Supported Regulatory Pipelines
Compliance Journeys We Power
Whether you're preparing for FDA submissions, HIPAA audits, or ISO certifications — Fignos adapts to your compliance path with AI-driven readiness.
✅ Built to support your full compliance journey — from research to commercialization.
Built for Your Regulatory Journey
Whether you build medical devices, digital health platforms, or AI-first clinical tools — Fignos adapts to your vertical with compliance workflows, readiness scores, and regulator-grade traceability.
Built for Med Device Startups
Navigating 21 CFR and ISO 13485? Manual SOPs and audits slow you down. Fignos automates compliance, helping you launch faster — with audit readiness built in.
Document Builder
Align SOPs with ISO 13485 & 21 CFR Part 820 — audit trails built in.
CAPA Manager
Resolve nonconformities with traceable corrective actions and workflows.
Regulation Monitor
Get real-time alerts and impact mapping for FDA and ISO changes.
Readiness Engine
Generate audit checklists, validate documents, and score readiness.
Built for Audit Readiness. Proven for Trust.
Every step in Fignos gets you closer to investor-grade, regulator-grade, and board-grade trust — without slowing you down.
Start With What You Already Have
Document Hub
Use your existing SOPs, policies, and folders. Fignos brings them under audit-grade version control — instantly.
💡 No setup. No migration. Full traceability from day one.
Know Exactly What You're Missing
Readiness Engine
Auto-generate your audit checklist from HIPAA, ISO 13485, 510(k), and GMLP — and map what's done vs. what's not.
💡 Zero guessing. Gaps identified in minutes.
Fix Risk Before It Becomes a Violation
CAPA Manager
Spot missing evidence, overdue policies, or unassigned actions. Fignos flags it before your auditor does.
💡 Audit blockers flagged. Nothing falls through.
Prove You're Ready for Investors, Auditors, and Regulators
Dossier Builder + AI Trust Lens
Export your full compliance dossier — backed by real-time readiness scores, GMLP alignment, and evidence trails.
💡 Not just compliant. Investor-trusted. Audit-grade.
The Fignos Advantage
Enterprise-grade compliance automation — built for healthtech, med devices, and AI-first teams.
Structured on QMS, Built for Speed
Fignos combines ISO 13485 and FDA 21 CFR Part 820 principles with modern document automation — no training wheels needed.
Covers: Document Hub, Document Builder, CAPA Manager
Automated Readiness. Checklist to Dossier.
From instant checklist generation to regulation tracking and auto-linked audit reports — Fignos tracks everything that moves.
Covers: Readiness Engine, Regulation Monitor, Compliance IQ
AI-Aligned, Investor-Ready
Built for AI/ML teams with GMLP validation, trust scoring, and audit-ready logs for regulators, boards, and VCs.
Covers: AI Trust Lens, Dossier Builder
Fignos helps you scale trust — across documents, audits, submissions, and AI validation.