Regulatory Roadmap

Trigone is currently an investigational platform. It is not a medical device and has not been cleared or approved by the FDA, EMA, or any other regulator for clinical use. This page describes our intended direction. It is forward-looking, and the specifics will depend on intended use, risk classification, and jurisdiction.

Designed for regulation from the start

Much surgical AI struggles to become a product because it was never built to be one. We took the opposite approach. Consistency, auditability, and privacy are built into the platform, so the path from where we are today to a regulated product is about evidence and documentation, not a rebuild.

A phased path

Phase 1. Research and platform (today)

Build a rigorous, dependable foundation, develop and validate our models, and conduct careful evaluation. No clinical claims.

Phase 2. Clinical evidence

Studies with clinical partners to measure accuracy, reliability, and clinical value, with clear endpoints and honest reporting.

Phase 3. Quality system and controls

Establish a quality-management system and software lifecycle aligned with recognized standards, for example ISO 13485 for quality management, IEC 62304 for medical-device software, and ISO 14971 for risk management, and adopt the IMDRF Software-as-a-Medical-Device framework for intended-use and risk categorization.

Phase 4. Regulatory submission

Pursue the appropriate pathway for the intended use and risk class, such as an FDA submission in the United States and CE marking under the EU Medical Device Regulation in Europe, including a change-control plan where relevant.

Phase 5. Post-market

Monitor real-world performance, watch for drift, and manage updates under change control and post-market surveillance obligations.

Principles that lower risk

• Human-in-the-loop. Decision support with a clinician in control is generally lower-risk than autonomous action.
• Auditability. Outputs can be traced and reviewed.
• Consistency. Results are dependable and can be relied upon.
• Transparency. We document intended use, limitations, and how the platform should and should not be used.

Honest disclaimer

Nothing on this page is a representation that Trigone is or will become cleared, approved, or CE-marked, nor a commitment to a specific timeline. We will update this roadmap as our evidence and regulatory strategy develop. Questions from partners and reviewers are welcome at contact@trigone.net.