Spreadsheets and wikis weren't built for requirements
Manual linking is slow and merge conflicts recur. Wikis are great for brainstorming, but neither has native version control, review, or approval, so getting audit ready means rework.
Software for product quality and compliance
Quality differentiates you from your competition.
Traceable keeps your requirements, documents, and approvals in sync as the design changes, so everything stays traceable and audit ready without the busywork.
why use traceable?
Developing high-quality products carries a hidden cost, most of it in maintaining the documentation.
THE PAIN POINTS
The solution
One platform where documentation stays in sync.
Traceable keeps requirements, documents, and approvals connected as the design changes, so everything stays traceable and audit ready without the busywork.
Structured templates, not blank sheets
Start from templates aligned with IEC 62304, ISO 13485 and ASPICE, with built-in version control, review, and approval from day one.
Live traceability that can't silently break
Every requirement carries a TraceID. Links across documents stay valid as things change, and coverage stays live in the matrix.
Control and audit built in, not bolted on
Row-level change logs, gated e-signature releases, and an immutable PDF snapshot on every publish. Your QMS lives where you work.
AI that stays consistent and reviewable
Generate faster with a consistent approach across the team, every output stays in a controlled, human-reviewed flow regulators expect.
Key features
Everything a regulated team needs, in one place.
Templates, traceability, review workflows, and version control for the entire documentation lifecycle.
UN-001A
User Needs
SRS-001B
Requirements
TST-001A
Test Plan
01
Document templates
Start every document from a structured template aligned with IEC 62304, ISO 13485 and ASPICE.
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 Apr
v1.325 AprRevised alarm timing
03
Revision control
Track every change down to the requirement, with diffs and rollback.
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.
Audit Package · ISO 13485
Design Inputs
Risk Management File
V&V Records
06
Immutable snapshots
Every publish captures a locked PDF snapshot, so you always have the exact document that was approved.
How it works
From blank page to audit-ready, in one controlled flow.
Release 1 covers the core platform: author, trace, control, review, and publish regulated documents, each step wired to the next so nothing falls out of sync.
Available now · Release 101
Author
Write in a structured canvas from IEC 62304 and ISO 13485 templates, text, tables, and requirement grids, not loose prose.
TemplatesAuto-save
02
Trace
Give every requirement a database-backed TraceID and link across documents. Coverage stays live in the matrix and document map.
TraceIDsRTM
03
Control
Every draft keeps a row-level change log with comments, mentions, and a published / draft / fix version model.
Change logComments
04
Review & sign
Publishing is gated: comments resolved and e-signatures captured with each signer's identity and a timestamp.
e-SignaturesGated release
05
Publish
Each release captures an immutable PDF snapshot and a revision table generated from the document's published history.
PDF snapshotRevision table
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
The team
One source of truth for every role on the project.
Traceable replaces a dozen disconnected tools with a single hub, every role connects to the same live documents.
Project Manager
Systems Engineer
Quality Engineer
Software Developer
Test Engineer
UX Designer
Regulatory Affairs
Executive
Pricing
A plan that scales with your team.
From a solo regulatory consultant to a connected quality program, Traceable fits the shape of the team using it. Reviewers and auditors are always free.
Annual saves 2 months
Solo
For solo consultants and freelancers managing a single project.
$49USD / mo
per seat / month- Create projects and documents
- 25 documents included
- Live requirement linking and traceability
- Publishing and e-signatures
- Single user (no organisation)
Add-ons
- + $49MCP for external AI authoring
- + $50Additional 25 documents
Most popular
Business
For teams shipping a regulated product together.
$249USD / mo
base / month- Everything in Solo
- Organisation and collaboration
- 1 Admin and 2 Contributor seats included
- Reviewers and auditors free
Add-ons
- + $69Contributor seat
- + $49MCP for external AI authoring
- + $99Additional 50 documents
Business Pro
For organisations running larger, connected quality programs.
$399USD / mo
base / month- Everything in Business
- Integrations
- Automated workflows
- MCP for external AI authoring
Add-ons
- + $109Contributor seat
- + $99Additional 50 documents
Prices shown in USD. Reviewer and auditor seats are always free.
Help shape the future of this software.
Tell us about your company, your product, and your documentation pain points, and let's work together.