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
Design changes after launch: how to scope validation without starting over
Find what a post-launch change really touches, re-verify that, and record why the rest still stands.
PMA readiness: closing DHF gaps before the audit
The design history gaps inspectors find first, and how to close them before a premarket approval.
DHF remediation for scaling medtechs
How to bring an incomplete design history file back to a defensible state, and keep it there.
Using AI in a validated documentation process
How to let your team use AI on controlled documents without losing control of them.
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 clauses 4.2.4 and 4.2.5 expect, and how to meet them 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 under the QMSR, how it relates to the medical device file, 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.
How to write good requirements
The characteristics of a good requirement, the pitfalls, and how to keep them traceable.
Functional vs non-functional requirements
What the product does vs how well it does it, with examples.
Verification vs validation
Building it right vs building the right thing, and why both trace to requirements.
How to create a requirements traceability matrix
Six steps to a working RTM, and how to keep it current.
See Traceable on your own documents
Import your existing requirements and see live traceability in minutes.