1. Purpose of the gate
Chip and board designs are complete and frozen for verification and type test builds; later changes go through change control with an impact analysis on safety, security and certification.
This gate freezes the hardware that will be verified, type tested and certified. After it, every change goes through change control with an impact analysis on the FMEDA, spacing, EMC and certification evidence. Reviewers check that the design is complete, that it implements the safety concept, and that the preliminary FMEDA shows the hardware metrics can be met.
Spacing and isolation checks matter here because a barrier that fails type test after certification samples are built costs a full rebuild. Component approval matters because the supply life commitment depends on every safety and long-life component being available for the period promised.
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