SME
Biomaterials · Problem type
Design controls
Use this for “Put validation, design inputs, user needs, design transfer, design outputs and verification in the order a device design follows.”
Put in order
Put the design-control stages in order.
1
?
2
?
3
?
4
?
5
?
6
?
Assumptions
•
Design controls are the steps a regulator expects a device maker to follow and record.
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Verification asks “did we build it right?”: the outputs meet the inputs, checked by tests on the bench.
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Validation asks “did we build the right thing?”: the device meets the user needs, checked with users.
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