Traced
Made by devs who hate compliance
Compliance that lives in your code.
Let Cursor and Claude Code write it while you ship code.
---
itemId: treatment-planning
itemType: Requirement
itemState: Approved
riskClass: B
---
# Treatment Planning System
The system shall provide treatment planning capabilities
that allow clinicians to configure therapy parameters
based on patient-specific anatomical models.
## Acceptance Criteria
- [ ] Supports multiple treatment modalities
- [ ] Generates patient-specific parameters
- [ ] Validates against safety constraintsRequirements, architecture, risks, and tests — all as markdown files with YAML frontmatter, versioned in git. Traced guides you through what you need to write, then generates the traceability matrices, risk files, and audit reports that regulators expect. No Jira. No Word docs. No $50k/year platforms.
See exactly how requirements flow to design, tests, and risk controls. Generated from your markdown. Always in sync.
| Requirement | Design Item | Test Case | Risk Control | Status |
|---|---|---|---|---|
|
REQ-001
Treatment Planning
|
SWI-012
Planning Module
|
TST-045
Plan Validation
|
RSK-003
Operator Review
|
Complete |
|
REQ-002
DICOM Import
|
SWI-008
PACS Connector
|
TST-022
DICOM Parse
|
— | Complete |
|
REQ-003
Thermal Simulation
|
SWI-015
FDTD Solver
|
— Missing |
RSK-007
Validation Study
|
Gap |
|
REQ-004
User Authentication
|
SWI-003
Auth Service
|
TST-011
Login Flow
|
RSK-012
Access Control
|
Complete |
ISO 14971 compliant risk management. Track initial and residual risk, link controls to hazards, and visualize your risk acceptability.
| Hazard | Initial | Control | Residual |
|---|---|---|---|
|
Incorrect dose calculation
RSK-003
|
C3 | Operator verification + validation study | A1 |
|
Data corruption
RSK-007
|
B2 | Checksums + backup | A1 |
|
Unauthorized access
RSK-012
|
B3 | MFA + role-based access | A2 |
|
System unavailability
RSK-015
|
B2 | Redundancy + monitoring | A1 |
Generate the exact documents auditors expect. One click to export your complete technical file for FDA submissions or notified body reviews.
IEC 62304 §5.2 compliant SRS with full requirement traceability
Component breakdown with safety classifications and SOUP analysis
ISO 14971 compliant RMF with hazard analysis and FMEA
Bidirectional links from requirements to verification
Verification & validation results with test coverage analysis
SOUP/OTS inventory with license compliance and CVE tracking
It's just markdown in your repo. Cursor and Claude Code can read your code and generate compliant docs.
Same PR review. Always in sync.
Most solutions assume you live in Jira. But your code lives in git. Your tests run in CI. Your docs are markdown. Why should compliance be different?
$50k+/year contracts designed for large pharma. Startups building medical devices deserve better.
Built for project managers, not engineers. Your V Table shouldn't live in a ticket system.
Compliance lives in one system, code in another. Good luck keeping them in sync during an audit.
Traced plugs into your existing pipeline.
One plan. Everything included. No enterprise sales calls.
Per project. Unlimited users.
We're building Traced for developers who ship regulated software. Join the waitlist to get notified when we launch.