Run by the program manager before the stage's closing gate, to confirm its outputs, reviews and decisions are complete.
MustThe design and development plan sets stages, design reviews, verification, validation and transfer activities with owners.
MustThe risk management plan sets acceptability criteria from the organisation's policy.
SeeDecision: Risk acceptability criteriaStandard: ISO 14971
MustThe software development plan sets processes for the initial software safety class.
SeeStandard: IEC 62304
MustThe applicable standards list names the general, collateral and particular standards with editions.
MustThe design history file structure is open under document control.
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