Design control software with traceability built in
Manage design inputs, outputs, verification, validation, and the design history file in one place, with live links that keep everything traceable as the design changes.
Inputs, outputs, and the traces between them
Design inputs and outputs
Capture inputs and outputs as structured, linked requirements, so every output traces back to the input it satisfies.
Verification and validation
Link each requirement to the verification and validation that covers it, and see gaps through the traceability matrix.
Design history file
Versions, approvals, e-signatures, and immutable snapshots build up the records a design history file needs, in one controlled place.
Built for 21 CFR 820.30 and ISO 13485
Design controls are described in FDA 21 CFR 820.30 and ISO 13485 section 7.3. Both expect a documented, traceable path from user needs and design inputs through outputs to verification and validation, captured in a design history file. Traceable is built to manage exactly that path, with live trace links and audit-ready records, for teams building medical devices.
The tool helps you produce and maintain this evidence. It does not, on its own, make an organisation compliant or certified: that remains the responsibility of your quality system and process.
Common questions
What are design controls?
Design controls are the documented process regulators expect for medical device development: capturing design inputs, producing design outputs, verifying that outputs meet inputs, validating that the device meets user needs, and maintaining a design history file. FDA 21 CFR 820.30 and ISO 13485 section 7.3 describe them.
How does Traceable support design controls?
Traceable links design inputs to outputs and to the verification and validation that cover them, with a requirements traceability matrix that stays current. Review, e-signatures, and immutable snapshots produce the records a design history file needs.
Does Traceable build the design history file for me?
Traceable keeps the documents, versions, approvals, and traceability that make up a design history file in one controlled place, so assembling it is an export rather than an archaeology project. It supports the DHF; it does not replace your quality process.
See design controls traced end to end
Import your design inputs and see verification coverage in minutes.