Complear OS
The Infrastructure for Agentic Compliance in Digital Health
Build your innovations on the world's first Agentic Compliance Management System (aCMS).
Complear OS is the intelligent infrastructure where Human Agents and AI Agents seamlessly collaborate. We orchestrate your entire regulatory workflow—from Medical Device safety to AI governance and Data Privacy—ensuring continuous compliance that scales with your product.
The Agentic Difference
How the "Agentic" Workflow Works
Compliance is no longer a static task—it's an autonomous process with Human-in-the-Loop oversight.
In a highly regulated industry, you cannot rely solely on automation. Complear OS provides the structured environment where AI and Humans work as a unified team.
🤖 AI Agents (The Doers)
Our AI agents work autonomously to draft requirements, monitor regulatory changes, run regression tests, and flag inconsistencies across your ISO 13485 and ISO 27001 frameworks. They act as your first line of defence, handling the heavy lifting of data management and verification.
👤 Human Agents (The Deciders)
Critical decisions never happen in a black box. Humans remain the ultimate authority, reviewing AI proposals, approving "Gate Reviews," and handling high-risk judgments. The system ensures humans are always kept in the loop for final validation.
🔄 The Orchestration Engine
Complear OS is the infrastructure that enforces the rules of engagement. It ensures that every AI action is logged, validated, and routed to the right human expert for approval, maintaining a continuously audit-ready state.
AI Agent
Detects & Drafts
Complear OS
Validates & Routes
Human Expert
Reviews & Approves
Infrastructure & Adaptability
Adaptive Infrastructure for Every Stage of the Value Chain
From concept to market, and from startup to enterprise ecosystem.
1. Tailored to Your Product Stage
🌱 Concept & Design (Start)
Focus on Feasibility
The OS activates "Lite" frameworks to help you classify your product ("Is this a medical device?"), define intended use, and capture early design controls without administrative bloat.
🚀 Market & Scale (Growth)
Full-Scale Compliance
As you move to certification, the OS expands to full-scale compliance. It activates rigorous Post-Market Surveillance (PMS), Clinical Evaluation updates, and multi-market regulatory tracking (FDA + MDR + AI Act).
2. Unified Stakeholder Ecosystem
For Manufacturers
Centralize your R&D, Quality, and Regulatory teams on one platform. Break down silos between software code (Jira/GitHub) and compliance documentation.
For Hospitals & Procurement
Use Complear OS as a "Quality Gate." Instantly audit incoming digital health solutions from third-party vendors to ensure they meet your internal security and safety standards before deployment.
For Auditors & Notified Bodies
Grant "Auditor View" access. Allow external reviewers to see a live, transparent view of the compliance evidence, speeding up certification reviews.
User Story
See Agentic Compliance in Practice
From "Code Commit" to "Audit Ready" in minutes.
Imagine Sarah, a Lead Developer at a Digital Health scale-up. She just pushed a code update for a new AI diagnostic feature to GitHub.
The Trigger
Complear OS detects the code change via integration.
The AI Agent Acts
An AI Agent analyzes the code update against the existing Technical File. It notices the new feature affects the "Cybersecurity Risk Analysis" and automatically drafts an updated Risk Assessment entry.
The Human Loop
Complear OS flags this update for David, the Quality Manager. He receives a notification: "New AI feature detected. Risk Assessment update proposed."
The Resolution
David reviews the AI's proposed risk update. He adds a minor comment and clicks "Approve."
The system instantly updates the Technical File version, logs the change for the audit trail, and syncs the status back to the project dashboard. Total compliance continuity without slowing down development.
Compliance Coverage
Exclusive Focus on Digital Health Regulations
We speak the native language of software-based healthcare.
Medical Device
- MDR (2017/745)
- IVDR (2017/746)
US FDA
- 21 CFR Part 820
- 510(k) Submissions
AI Governance
- EU AI Act
- ISO/IEC 42001
- ISO/IEC 5338
Data Privacy & Security
- GDPR
- HIPAA
- ISO 27001
Cybersecurity
- ISO/IEC 62304
- EU Cybersecurity Act
Secure Your Infrastructure for the Future
Schedule a personalized walkthrough of the Complear aCMS. To ensure we tailor the demo to your specific needs, please tell us a bit about your infrastructure requirements: