Low-cost requirements management for medical device startups
Start on the Free plan with 1 author and 1 project, then move to Essentials at US$35 per author per month as the team grows. Design controls, live traceability and e-signatures from the first document, without an enterprise contract.
Traceable gives an early-stage medical device team requirements management, a live traceability matrix and e-signatures without an enterprise contract. Free costs nothing for one author, paid plans are priced per author with the prices published, and the templates follow the structure that IEC 62304 and ISO 13485 documentation expects.
Published prices, per author
Pay only for the people who write. Reviewers and auditors are free on every plan. Prices exclude GST.
Free
Free
1 author and up to 3 reviewers. 1 project, 10 documents. Traceability, review and e-signatures. MCP, rate-limited.
Essentials
US$35 (A$52) per author a month
Up to 5 authors. Reviewers and auditors free. 3 projects, unlimited documents. MCP included.
Team
US$64 (A$96) per author a month
2 to 50 authors. Unlimited projects and documents. Design Phase board and branches. Traceability matrix export.
Regulated
US$119 (A$178) per author a month
3 or more authors. Everything in Team. 21 CFR Part 11 signing. Distinct signers on every review.
Annual billing gives two months free. The full comparison, with Enterprise, is on the pricing page.
Design controls from the first document
Design controls
Manage design inputs, outputs, verification and validation with traceability throughout. See design control software.
IEC 62304 from the start
Work through the deliverables by software safety class with the free IEC 62304 checklist, and start documents from templates aligned with the standard.
ISO 13485 document control
Controlled documents with revisions, review and approval, and a full change log, the kind of record ISO 13485 document control expects.
Live traceability matrix
User needs, requirements, risks and tests linked by database-backed TraceIDs, with coverage in a requirements traceability matrix that stays current on its own.
Review and e-signatures
Publishing is gated on resolved comments and completed e-signatures, on every plan, including Free.
Immutable snapshots
Every publish captures a locked PDF snapshot, so you always have the exact document that was approved.
Set up the discipline before the team is big enough to need it
The cheapest time to get traceability right is before there is much to trace. A startup that keeps requirements in a spreadsheet and documents in a shared drive usually rebuilds both the month before its first audit or submission, and the links between them are the part that has to be reconstructed by hand.
Traceable lets you start that discipline on the Free plan with a real document set, then add authors and projects as the device and the team grow, without migrating to a different tool. For the full medical device picture, including risk and hazard analysis in line with ISO 14971, see Traceable for medical device teams.
Common questions
How much does requirements management cost for a medical device startup?
Free costs nothing for 1 author on 1 project with up to 10 documents. Essentials is US$35 per author per month (A$52), Team is US$64 (A$96) and Regulated is US$119 (A$178). Reviewers and auditors are free on every plan, and prices exclude GST.
Does Traceable make us IEC 62304 or ISO 13485 compliant?
No tool can do that on its own. Traceable ships templates with structure aligned to standards such as IEC 62304, ISO 13485 and ISO 14971, and keeps the traceability, review and signature records those standards expect. It helps you produce and trace the documentation. It does not by itself make an organisation certified.
Can our regulatory consultant or an auditor review without a paid seat?
Yes. Reviewer and Auditor roles are free. Free allows up to 3 of them, and every paid plan allows as many as you need, so bringing in a consultant or an auditor does not add to the bill.
Can we start small and grow into it?
Yes. Every new organisation starts with a 30-day trial of Team. When it ends you choose a plan, or stay on Free and keep everything you made, with Free's limits on anything new.
Does Traceable support 21 CFR Part 11?
The Regulated plan adds 21 CFR Part 11 signing and distinct signers on every review. These are designed to support Part 11 style workflows. Formal Part 11 clearance is on the roadmap, so we describe these features as supporting your process rather than certifying it.
Start your design history on the Free plan
Create your first project and publish a signed, traceable document in an afternoon.