UN-001Rev A
User Needs
SRS-001Rev B
Requirements
TST-001Rev A
Test Plan
01
Document templates
Start every document from a structured template aligned with IEC 62304, ISO 13485 and ASPICE.
Software for product quality and compliance
Quality differentiates you from your competition.
Traceable is an AI-native platform for product development teams — keeping documentation in sync with design changes and audit-ready, without the busywork.
In the lab
The problem
Developing high-quality products carries a hidden cost — most of it in maintaining the documentation.
- Too much of our time goes to documentation, generating no value
- Tools were built for paper, not for software-defined products
- Audits become fire drills because traceability lives in spreadsheets
- Every change cascades into hours of manual rework across documents
Key features
Everything a regulated team needs — in one place.
Templates, traceability, review workflows, and AI assistance for the entire documentation lifecycle.
SRS-001 · Rev B
J. Tan · Approved
R. Kim · Approved
M. Patel · In review
02
Review & approval
Built-in review workflows with electronic signatures, deadlines, and audit trails.
v1.112 MarInitial release
v1.202 AprUpdated tidal volume tolerance
v1.325 AprRevised alarm timing
03
Revision control
Track every change down to the requirement, with diffs and rollback.
UN-014User Need
REQ-024Requirement
HAZ-007Hazard
TST-014Test
04
Live traceability
Links between requirements, hazards, and tests stay valid as documents evolve.
REQ-024Basal delivery ±5%Functional
REQ-025Alarm on interruptSafety
REQ-026Battery ≥ 7 daysPerformance
05
Structured content
Edit requirements, hazards, and tests as data — not paragraphs to grep through.
Refactor REQ-024 to be testable.
Suggested: “The pump shall deliver basal insulin within ±5% of the programmed rate, verified per TST-014.”
06
AI co-author
Draft, refactor, and check requirements with an AI that knows your project context.
How it works
Built for every role on your project.
Traceable keeps your documents, requirements, and approvals in sync automatically — so every role on your team can focus on the work, not the paperwork.
01
Always in sync
Live links across documents — change a requirement and every affected doc updates.
02
Built for review
Approvals, electronic signatures, and a full audit trail built into every document.
03
AI that knows your project
Draft, refactor, and gap-check requirements with context from your whole project.
Project Manager
"I can see every blocker without chasing people on Slack."
Systems Engineer
"My requirements stay in sync with the design — automatically."
Quality Engineer
"Audits go from a fire drill to a five-minute export."
Software Developer
"I document as I code, not in a Friday afternoon scramble."
Test Engineer
"Every requirement comes with the tests that verify it."
UX Designer
"User needs flow through every downstream document."
Regulatory Affairs
"My submission packages are ready before the project ends."
Executive
"I finally see project status without a status meeting."
Built for regulated industries
Compliance, by design.
Traceable maps directly to the standards your industry requires — so audits become an export, not a project.
IEC 62304 · Medical device software lifecycle
ISO 13485 · Medical device QMS
ISO 14971 · Risk management
ASPICE · Automotive SPICE
21 CFR 820 · FDA Quality System
21 CFR 11 · Electronic records & signatures
Pricing
A plan that scales with your team.
From a solo regulatory consultant to an enterprise quality program — Traceable fits the shape of the team using it.
Individual
For solo consultants and freelancers managing a single project.
Contact for pricing
- 1 active project
- 3 user seats
- Core document templates
- AI ready
Most popular
Team
For product teams shipping a regulated product end-to-end.
Contact for pricing
- Up to 10 projects
- 25 user seats
- Core document templates
- Review Log + eSignatures
Business
For organisations running multiple programs across product lines.
Contact for pricing
- Unlimited projects
- 100 user seats
- SSO + SCIM
- Advanced compliance exports
- Dedicated CSM
Enterprise
For regulated enterprises with audit, security, and scale needs.
Contact for pricing
- Unlimited everything
- Custom data residency
- Audit log streaming
- SLA + security review
- 24×7 support
Help shape the future of this software.
Tell us about your company, your product, and your documentation pain points — and let's work together.