Guides on traceability, requirements, and document control
Practical, vendor-neutral guides for teams building regulated products. Educational explainers of the standards and practices, not certifications.
Latest guides
What is requirements management?
What it is, why it matters, the core process, and the role of traceability.
IEC 62304: a practical guide
Software safety classes, key deliverables, and the role of traceability.
Medical device software development
Safety classification, life-cycle activities, and the traceability that ties them together.
ISO 13485 document control
What clause 4.2 expects, and how to meet it without the manual overhead.
ISO 14971 risk management
The risk process, and why risk traceability is the part that breaks.
Design history file (DHF)
What a DHF contains, how it differs from the DMR, and how to keep it audit-ready.
Document control for medical devices
Controlled documents in an ISO 13485 quality system, produced as a by-product of work.
Traceability matrix for medical devices
From user needs to verification, and how to keep the matrix honest between audits.
See Traceable on your own documents
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