Module spotlight: Design Control
Design control turns a concept into a verified, validated product. It is the structured backbone of development — and one of the areas regulators scrutinise most.
By MoniDoseQMS Team
When you have a product, you need design control. It is the structured process that connects what your product must do to proof that it does it — design inputs become outputs, outputs are verified against inputs, and the finished product is validated against real user needs.
What you can do
- Run design projects from concept through to manufacturing transfer
- Capture design inputs, outputs, verification, and validation with traceability
- Manage configuration items and label masters
- Track design changes through change control
Why it matters
Design control is required by ISO 13485 §7.3 (incorporated into the FDA QMSR, 21 CFR Part 820), EU MDR Article 10 and Annex II — and, for software, runs alongside the IEC 62304 lifecycle. Built-in traceability from requirement to test is what makes a design history reviewable rather than a pile of disconnected files.
See how MoniDoseQMS handles this
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