Guide
Design controls for medical devices: a practical guide
Design controls are the documented process that turns user needs into a safe, effective device you can manufacture. ISO 13485:2016 clause 7.3 describes them, and the FDA QMSR applies them through that standard. The result is a design history that proves every requirement was met.
The stages
From user needs to production
Planning and inputs
A design plan sets stages, reviews and responsibilities. Design inputs turn user needs into clear, testable requirements, including regulatory and risk requirements.
Outputs and reviews
Outputs are the drawings, specifications and software that define the device. Formal design reviews at planned stages check progress.
Verification and validation
Verification shows outputs meet inputs. Validation shows the finished device meets user needs in its intended use, including usability and clinical evaluation where needed.
Transfer and changes
Design transfer moves the design into production. Design changes are reviewed, verified or validated, and approved before they are implemented.
Doing it well
Habits that pass audits
- 1Start the design plan early and update it as the project changes.
- 2Write inputs that are measurable, so each one has a clear verification method.
- 3Keep a traceability matrix linking needs, inputs, outputs, tests and risk controls.
- 4Tie design reviews to decisions, with an independent reviewer and signed records.
- 5Run design changes through change control so the design history stays complete.
Where Qevatrix fits
Design history with traceability built in
QualityOS keeps design plans, inputs, outputs, reviews, verification, validation and changes linked in one record, with Part 11 signatures and a rule that nobody approves their own work.
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This guide is an orientation, not regulatory advice. Confirm requirements against ISO 13485:2016 clause 7.3, the FDA QMSR and the regulations of each market you sell in.