Design and development inputs/outputs
Inputs relating product requirements shall be determined and records maintained. Inputs shall be reviewed for adequacy and must be unambiguous and not in conflict with each other.
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- functional and performance requirements
- statutory and regulatory requirements, if applicable
- information derived from similar designs
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The outputs of design and development shall be provided in a form allowing verification against inputs, and shall be approved prior to product release.
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- meet the input requirements
- provide information for purchasing, production and service provision
- contain or reference criteria for product acceptance
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