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How to Master Design Output?
A design output is the tangible evidence that a design element has been implemented, the drawings, specifications, procedures, or code… that bring design requirements to life.
The right format depends on the device, but it must comply with ISO 13485 (7.3.3) and integrate risk management from the very beginning.
Risk analysis is not a separate stage : it is an ongoing process that improves and iterates the design.
Design outputs may be:
Assembly drawings
Material specifications
Process documentation
Software source code
Work instructions
QA procedures
Installation guides
Packaging and labeling specifications
Many others formats depending on the complexity of your device…
That’s where a tool like Matrix Req helps:
✓ It lets you capture, document, and manage all design requirements, design outputs, and Verification/validation tests in one centralized place.
✓ Teams can access, review, and update everything across the full product lifecycle.
Download our guide now for more details!
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