AI Governance Solutions
Build responsible, compliant, and trusted AI solutions with Complear's expertise and digital tools. We help manufacturers, deployers, and healthcare innovators navigate the rapidly evolving landscape of AI regulation, from registry obligations to risk management and certification.
AI Registry with Complear OS
Automate your AI Registry compliance with intelligent solutions.
Simplify Registry Compliance
The EU AI Act (Article 49) mandates that high-risk AI systems must be registered in a centralized EU database. Complear OS offers a seamless solution to help you build and maintain your AI Registry entries, ensuring compliance with regulatory requirements without the hassle.
From initial documentation to updates and monitoring, Complear OS streamlines the process, helping you stay audit-ready and build transparency with authorities and users.
Key Benefits of Registry Automation
Compliance Assurance
Stay compliant with the EU AI Act's registration requirements through automated documentation and submission processes.
Streamlined Updates
Easily manage version updates, modifications, and ongoing monitoring requirements for your AI systems.
Transparent Documentation
Build trust with stakeholders through comprehensive, well-structured registry entries that demonstrate your commitment to responsible AI.
Regulatory Landscape
EU AI Act
Comprehensive compliance with the EU's new regulatory framework for artificial intelligence
FDA AI/ML Guidance
Alignment with FDA's evolving guidelines for AI/ML-based Software as a Medical Device
Industry Applications
Regulatory Compliance for Manufacturers (EU and US)
Prepare your AI solutions for regulatory success across Europe and the United States. Complear supports AI manufacturers at every step of the regulatory journey — whether you're building Clinical Decision Support Software, AI tools for diagnostics, or other healthcare-related applications.
Our team helps you comply with the EU AI Act requirements, FDA AI/ML guidelines, and applicable frameworks for software as a medical device (SaMD).
We offer services ranging from AI risk classification, conformity assessment support, quality management system integration (ISO 13485, ISO 42001), to technical documentation drafting, all tailored for AI-driven innovations.
Deliverables include:
- AI Risk Classification and Strategy
- Regulatory Roadmap for EU and US
- Technical Documentation Support
- Conformity Assessment Preparation
- Ongoing Compliance Advisory
EU AI Act Regulatory Compliance for Deployers
Support for companies deploying third-party AI systems in Europe and beyond.
Meet Deployer Obligations
The EU AI Act introduces significant obligations for deployers of high-risk AI systems. Even if you didn't develop the AI, your organization must ensure its responsible and compliant use. At Complear, we help healthcare providers, research institutions, and enterprises integrate AI solutions while meeting all regulatory requirements.
Using Complear OS, you can track how third-party AI tools are deployed across your organization, document usage and potential risks, and stay ready for supervision and audits.
DPIA, AISIA & FRIA Management
Data Protection Impact Assessments, AI System Impact Assessments and Fundamental Rights Impact Assessments tailored for AI systems.
Compliance Documentation
Maintain records and documentation required by the EU AI Act for deployers of high-risk AI.
Risk Monitoring
Ongoing monitoring of AI system performance and risk indicators to ensure continued compliance.
Incident Reporting
Procedures and support for reporting serious incidents and malfunctions to relevant authorities.
AI Management Standards
Complear offers advisory services to help you adopt and certify under leading AI Management standards. These frameworks provide structured approaches for responsible AI development, deployment, and oversight.
International standard for AI Management Systems (AIMS)
European standard for AI Management Systems in development
Our services include:
Documentation and Framework
- AI policy development
- Risk assessment framework
- Control implementation
Internal Audits
- Gap analysis
- Audit planning and execution
- Corrective action tracking
AIMS Management Training
- Leadership awareness
- Technical team training
- Continuous improvement
Our approach aligns AI management standards with sector-specific requirements, from healthcare AI compliance (like the EU MDR/IVDR and AI Act) to general enterprise deployment.
