Requirements management and traceability for medical device teams
Keep requirements, risks, and tests linked and audit ready as your device evolves. Traceable brings design inputs, verification, and documentation into one place, with templates aligned to the standards your submissions expect.
Working with
Oli Medical
From design inputs to an audit-ready file
Live traceability
Link user needs, requirements, risks, and tests with database-backed TraceIDs. See coverage in a requirements traceability matrix and a visual Document Map, with broken-trace detection.
Risk and hazard analysis
Risks are structured rows in an ID grid, with a classification column that reads each rating off your risk matrix, supporting hazard analysis in line with ISO 14971 and linked to the requirements that mitigate each hazard.
Design controls
Design controls are required by ISO 13485 clause 7.3, which the FDA's Quality Management System Regulation (QMSR) has applied since 2 February 2026. Manage design inputs, outputs, verification, and validation with traceability throughout. Trace design inputs through to verification and validation on the traceability matrix, and keep your design history file current as you go.
Standards-aligned templates
Start from templates aligned with IEC 62304, ISO 13485, and ISO 14971, so teams know where to begin.
Review and e-signatures
A publishing workflow gated on resolved comments and completed e-signatures, with a full change log.
Immutable snapshots
Every publish captures a locked PDF snapshot, so you always have the exact document that was approved.
Traceability is the hard part of medical device documentation
Medical device development lives or dies on traceability: every requirement should trace to a user need above it and to the verification below it, and every hazard should trace to the requirement that mitigates it. In spreadsheets and disconnected documents, those links are maintained by hand and quietly rot, so the traceability matrix is out of date by the time an auditor asks for it.
Traceable keeps the links live. When a requirement changes, affected documents update and broken traces surface immediately, so coverage stays honest between audits rather than being reconstructed before one. Standards such as IEC 62304, ISO 13485, and ISO 14971 shape the template structure, and the review, e-signature, and snapshot features are built to produce the evidence those standards expect.
Common questions
Does Traceable support IEC 62304 and ISO 13485 documentation?
Traceable ships a template library for common regulated document types (requirements, software requirements specification, risk, protocol, report, design review, phase gate, and release) with structure aligned to standards such as IEC 62304, ISO 13485, and ISO 14971. Traceable helps you produce and trace this documentation. It does not by itself make an organisation certified.
How does Traceable handle hazard and risk analysis?
Requirements and risks are edited as structured rows with risk and analysis column types (calculation, classification, dropdown, checkbox, test result, and summary). Hazards can be linked to the requirements that mitigate them and the tests that verify them, so risk traceability stays live.
Can I show a reviewer or auditor traceability quickly?
Yes. Coverage is visible through a requirements traceability matrix and a visual Document Map, and every published document carries an immutable PDF snapshot, a change log, and e-signatures.
Are Traceable e-signatures 21 CFR Part 11 compliant?
Yes. On the Regulated plan, Traceable has FDA 21 CFR Part 11 compliant e-signatures: two-step signing, timestamped and attributed records, and an immutable audit trail.
Put Traceable through its paces on a real project
Manage your risk before you commit: pick a live project, run it in Traceable, and judge it on your own documents.
Start with no cost
Pick a real project and run it in Traceable, with our team alongside you and onboarding and training included.
Support with setup
Your core requirements imported for you, a named contact and a weekly check-in.
Measured on your documents
Requirements linked and traced, a document reviewed, signed and published, and a PDF your eQMS accepts as is.
Your call at the end
Carry on with a plan, or stop. If you stop, we return your data to you and then delete it.
See traceability on your device documentation
Import your existing requirements and risk files, and see live coverage in minutes.