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.
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
Structured risk and analysis columns support hazard analysis in line with ISO 14971, linked to the requirements that mitigate each hazard.
Design controls
Manage design inputs, outputs, verification, and validation with traceability throughout. See design control software.
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and disconnected documents, those links are maintained by hand and quietly rot, so the traceability matrix is out of date by the time an auditor asks for it.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.
Is Traceable 21 CFR Part 11 compliant?
Traceable provides e-signatures and an audit trail 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.
See traceability on your device documentation
Import your existing requirements and risk files, and see live coverage in minutes.