Compliance automation tools
22 listings are filed under Compliance automation. Framework tags on these listings, by count: ISO/IEC 42001 (13), IEC 62304 (5), CMMC / NIST SP 800-171 (3), EU AI Act (3). Most-tagged industries: Cross-industry, Medical devices, Defense & national security. A tag appears only when the cited public page names it. Combine this type with other filters.
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6clicks (ISO 42001)
GRC with a pre-configured ISO/IEC 42001:2023 AIMS, Hailey AI mapping, SoA and Hub & Spoke. Cross-maps ISO 27001 and the EU AI Act. Homepage names SaaS, sovereign cloud or on-prem, and cloud, on-premises, air-gapped or hybrid.
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AI Cyber Innovations CMMC Compliance Platform
CMMC compliance platform with an AI policy generator and a CMMC chatbot: Level 1 gap assessment against the FAR 52.204-21 practices, evidence management, SSP generation and SPRS submission steps. A Professional tier is described as Level 1 + Level 2 ready. Early access.
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Aligned Elements
Medical-device ALM and eQMS for design-control and technical-file work. Homepage names pre-defined IEC 62304 Design Control templates. Regulatory-compliance page names IEC 62304-1:2015 software safety classification. Not an FDA PCCP product.
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AnnexOps
EU AI Act documentation generator: Annex IV technical documentation, Article 17 QMS, Article 43 conformity assessment, Article 47 declaration of conformity and Article 72 post-market monitoring plans, drafted from system data and SHA-256 hashed.
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Apptega (ISO 42001)
ISO 42001 compliance software with pre-built questionnaires, evidence collection, Audit Manager and harmonized multi-framework controls. Assigns tasks to internal teams and shares updates with auditors. The page names 12,000+ compliance programs and a Foresite Cybersecurity customer quote.
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ComplianceQuest Medical Device QMS
Salesforce-native QMS and PLM for medical device manufacturers. Official SaMD page names FDA Predetermined Change Control Plans (PCCP), IEC 62304 lifecycle requirements, cybersecurity documentation and IMDRF SaMD guidance. Not a model verifier.
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ControlMap (ISO 42001)
MSP-native GRC platform with ISO/IEC 42001 in a 63+ framework library: mapped controls, evidence and reporting. Partners import the framework to client tenants and cross-map against current frameworks. 2026 release notes add ISO 42001 Jump Start and an ISO 27001 crosswalk.
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Drata (ISO 42001)
Compliance automation that maps ISO 42001 AI-management-system controls, evidence, ownership and risk so enterprises can run an AIMS and stay audit-ready. Help Center also names an AIMS policy template and automated evidence collection. Not a model-assurance tool.
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ENVOLOK
Command-line program that checks a modification against an FDA-authorized Predetermined Change Control Plan before it ships. Official page: DEPLOY, BLOCK or UNKNOWN; offline; no network calls during evaluation. Not a QMS or model verifier.
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Greenlight Guru (SiMD/SaMD)
QMS and product-development software for software-enabled medical devices (SiMD/SaMD). Official page says the solution auto-generates audit-ready records to stay compliant with IEC 62304, linking tests and design changes to the DHF. Not an FDA PCCP authoring product.
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Hyperproof (ISO 42001)
Compliance operations platform with an out-of-the-box ISO 42001 AIMS template (Annex A) in a 160+ framework library. Guide covers Clauses 4–10, Annexes A–D and AI risk vs impact assessments. Crosswalks name NIST AI RMF. Audit Module for inviting the auditor.
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Iru (ISO 42001 compliance automation)
ISO/IEC 42001 readiness on Iru's compliance automation platform: endpoint inventory of installed AI tools for AIMS scoping, continuous evidence collection, AI-generated tailored controls, and a logged Statement of Applicability and risk treatment plan.
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ISMS.online (ISO 42001)
ISMS.online ISO 42001 page (Updated 14 July 2026): pre-configured templates and frameworks, dynamic risk management and document management. Certification described as valid three years with annual surveillance. ARM path from gap analysis to certification.
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Jama Connect for Medical Device & Life Sciences
Requirements, risk and V&V platform for medical device and life-sciences teams. Official frameworks list includes Medical Software Development: IEC 62304, plus FDA 21 CFR 820.30, EU MDR and ISO 14971. Suitably validated by TÜV SÜD for safety-related development. Not an FDA PCCP product.
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Scytale (ISO 42001)
Compliance hub for an ISO 42001 AIMS: automated evidence collection, 24/7 continuous control monitoring, auditor-approved policy templates, vendor risk management and an audit dashboard. Cross-maps common controls with ISO 27001.
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Secureframe (defense contractor offering)
CMMC and CUI platform for the Defense Industrial Base. Secureframe Defense automates enclave, documentation and monitoring; the CMMC page names GCC High, Defense Navigator, FedRAMP Moderate MDM and a CyberAB RPO listing. Not an AI-model assurance tool.
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Sprinto (ISO 42001)
Autonomous trust platform for an audit-ready ISO/IEC 42001 AIMS. Heading: Get ISO 42001 ready, minus the grunt work. 4,000+ customers; AI discovery across extensions, devices, integrations and SSO; real-time policy-drift reviews; one-click Trust Centre.
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Stages Process Management Software
Process-management software with bidirectional traceability between process models and standard objectives. Official table names ISO 26262, ISO/PAS 8800 and UL 4600 under Automotive; IEC 62304 under Medical devices; IEC 61508 and IEC 61511-1 under Industrial.
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Strike Graph (ISO 42001)
Compliance platform for ISO 42001 AIMS: pre-loaded mapped controls, 100% pre-built AIMS policy and procedure templates, Verify AI documentation checks, gap analysis, evidence dashboards and export to an external assessor.
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Thoropass (ISO 42001)
ISO 42001 compliance and audit platform with pre-built policy templates, an AI System Impact Assessment, automated evidence collection, a Risk Register, continuous monitoring, and one-audit-multiple-frameworks evidence reuse from a single platform.
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Vanta
Compliance automation covering ISO 42001, NIST AI RMF and CMMC (mapped to NIST SP 800-171/172). The ISO 42001 product page also maps evidence to the EU AI Act. Not an AI-model assurance tool.
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Vissibl
Management-system compliance platform with an ISO/IEC 42001 module: AI inventory, AI impact assessments, tracking of Annex A controls with a generated Statement of Applicability, internal audit, integrated with ISO 27001, 9001, 14001 and 45001 programmes.