Agile Compliance for Modern SaMD Teams

A Design History File (DHF) is a collection of records that describe the design and development process of a medical device, as required by FDA 21 CFR 820.30. It includes design inputs, outputs, verification, validation, and risk management documentation.

Yes. Tracewell AI helps teams prepare documentation for 510(k) submissions by extracting and organizing Design History File (DHF) elements—specifically design inputs, design outputs, and traceability—from tools like GitHub and your issue tracker.

While our current focus is 510(k) compliance, Tracewell's documentation engine can support many of the design control requirements common to both 510(k) and De Novo pathways. Support for De Novo-specific artifacts is planned.

Tracewell connects via OAuth and webhooks to sync issues, pull requests, and test artifacts. This allows us to automatically generate traceability matrices and maintain design control documentation in real time.

Tracewell is designed to help teams align with ISO 13485 requirements around design controls. While Tracewell does not guarantee certification, it provides the documentation structure auditors and reviewers expect.

Tracewell's AI-generated content is editable and reviewable by your team. You retain full control. Our goal is to accelerate documentation—not bypass your quality system review process.

Absolutely. Tracewell provides both automated and manual editing capabilities to ensure your DHF is audit-ready and tailored to your specific device.

Tracewell can assist in flagging potential documentation gaps, traceability issues, or incomplete verifications—but clinical risk management is still your responsibility. Our system is a compliance aid, not a replacement for a full QMS.

No. Tracewell is built for lean teams. While we don’t replace regulatory expertise, we help structure your existing engineering and product work into documentation aligned with FDA expectations—even if you don’t have a dedicated regulatory specialist.

Unlike traditional compliance tools, Tracewell is built for software-first teams. We focus on seamless integration with modern development stacks and leverage AI to reduce the manual burden of compliance documentation.