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Design and development review, verification and validation

At suitable stages, systematic reviews of design and development shall be performed, in order to evaluate if the results meet requirements and to identify any problems and to propose necessary actions.

Verification shall be performed to ensure that the design and development outputs have met the input requirements.

Validation shall be performed to ensure that the resulting product is capable of meeting the requirements for the specified operation or intended use.


Records of review, verification and validation shall be maintained.

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