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Automated compliance for FDA Cyber, EU AI Act, DORA, NIS2, and SOC 2. Evidence collection, control testing, and submission packs—done for you.

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Continuous Compliance & Evidence Automation

Automated Compliance forAI Act, FDA Cyber & DORA

Qwari ControlPlane™ automatically collects evidence, tests controls, and generates ready-to-submit compliance packs for emerging regulations. No more spreadsheets. No more hunting for screenshots.

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•1,000+ Reviews

Designed for innovative companies

MedTech Inc
AI Systems Co
FinServ Group
HealthTech Labs
Compliance Pro
SecureAI
MedTech Inc
AI Systems Co
FinServ Group
HealthTech Labs
Compliance Pro
SecureAI

Supporting Critical Regulatory Regimes

EU AI Act
Aug 2025-2027
FDA Cyber
June 2025
DORA
Jan 2025
NIS2
June 2026
SOC 2 / ISO
Ongoing

Continuous Compliance, Zero Manual Work

Connect your systems once. Evidence flows automatically. Submit to regulators in minutes.

Living Controls Library

Pre-mapped controls for AI Act, FDA, DORA, NIS2, SOC 2. Each control knows what evidence it needs, how to test it, and when to run checks.

Auto-Evidence Collection

200+ connectors pull logs, configs, SBOMs, and security settings from AWS, Okta, GitHub, scanners, and more—automatically linked to controls.

Submission Packs

One-click generation of FDA Pre-Market Cyber, AI Act Technical Documentation, or DORA ICT packs—ready to submit to regulators or auditors.

Built for High-Stakes Industries

Serving med-device, AI companies, and fintechs navigating complex regulations

Medical Device & SaMD

Automate FDA cybersecurity submissions with SBOM generation, threat modeling, patch management, and post-market surveillance—aligned to June 2025 guidance.

AI & High-Risk Systems

Prove EU AI Act conformity with model cards, data lineage, DPIAs, risk classification, and technical documentation—ready for notified body review.

Financial Services & Fintech

Meet DORA requirements with ICT third-party registers, incident classification, resilience testing, and board-level reporting—live Jan 2025.

Incident Response & Disclosure

Turn incidents into SEC 8-K filings or NIS2 reports in minutes with automated timeline assembly, impact analysis, and regulator-ready templates.

The Compliance Crisis is Here

Regulations have teeth. Budgets are unlocked. Companies need continuous compliance now.

$20B+
RegTech Market Size
200+
System Connectors
50+
Pre-Mapped Controls
5
Major Frameworks

Stop Chasing Compliance. Start Automating It.

Get your 90-day Submission & Surveillance Quickstart. We map controls, wire connectors, and deliver your first evidence pack.

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