Software for product quality and compliance

Build regulated products the way your teams already work.

Write in a familiar, document-style workspace while Traceable keeps every requirement linked, every change controlled and every approval recorded, so your evidence is audit ready the day you need it.

Authoring
Why use Traceable?

Release compliant products faster with less overhead.

Here is what slows regulated teams down, and what changes when the work lives in one place.

Holding you back

Files were never meant to manage a live design

“Keep it simple” is a good rule, but a product worth certifying is not simple. Files are passive: they cannot link a requirement to the test that proves it, version themselves, or show you the state of the whole design.

Every step in the flow adds another tool

Count them. From the first requirement to a formal release: template, document number, folder, authoring, review, export, publish, then a design change and around again. Every hop is somewhere work gets duplicated, delayed or lost.

Every role needs something different, and now so does AI

Engineering, quality, regulatory and approvers each need something different from the same document, and AI now drafts alongside them. The certifier still has to sign it off. One tool has to serve all of them and stay audit ready.

The solution

Live traceability that can’t silently break

Every requirement is linked, and those links stay valid as the design changes. Versioning is automatic, and the whole design stays visible in the traceability matrix and the document map.

One workspace, first draft to signed release

Start from templates built for the standards you work to. Numbering, authoring, review, approval and publishing all happen in one place, so there is no flow to map across tools and nothing to re-key.

Something for everyone in a controlled environment

An intuitive interface for writers, reviewers and approvers, an MCP for developers and a requirements tree for systems engineering. Every AI contribution, internal or external, is logged and needs human acceptance before it can be published.

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Key features

Everything a regulated team needs, in one place.

From the first requirement to a signed release, without leaving the workspace.

01

Document templates

Start every document from a structured template built for the standard you work to. Nobody begins from a blank page.

02

Review & approval

Reviews, deadlines and electronic signatures happen inside the document, and the audit trail writes itself as you go.

03

Revision control

See who changed which requirement and when, compare any two revisions, and roll back without losing the record.

04

Live traceability

Requirements, risks and tests stay connected as documents change, and a broken link surfaces before an auditor finds it.

05

Structured content

Requirements, risks and tests are data you can filter, link and report on, not paragraphs to search through.

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.

Author, trace, control, review and publish. Each step hands the next one everything it needs.

Available now · Release 1
01

Author

Write in a structured canvas from templates for the standards you work to: text, tables and requirement grids, not loose prose.

TemplatesAuto-save
02

Trace

Give every requirement a TraceID and link it across documents. Coverage stays live in the matrix and the document map.

TraceIDsRTM
03

Control

Every draft keeps a row-level change log with comments and mentions, under a published, draft and fix version model.

Change logComments
04

Review & sign

Nothing publishes until comments are resolved and e-signatures are captured, each with the signer’s identity and a timestamp.

e-SignaturesGated release
05

Publish

Each release locks an immutable PDF snapshot and generates the revision table from the document’s own 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
DO-178C · Airborne software
MIL-STD-882E · System safety
The team

One source of truth for every role on the project.

Traceable replaces a dozen disconnected tools with a single hub, so every role works from the same live documents.

Project Manager
Systems Engineer
Quality Engineer
Software Developer
Test Engineer
UX Designer
Regulatory Affairs
Executive
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
Get started

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
Get started

Prices shown in USD. Reviewer and auditor seats are always free.

Bring your next release into Traceable.

Tell us about your product and where the documentation hurts. We will show you the flow on your own documents, and your feedback shapes what we build next.