1. Purpose of the gate
Quality system regulations require design inputs to be reviewed and approved before design proceeds, and require incomplete, ambiguous or conflicting requirements to be resolved. This gate is that review. Once approved, the inputs are the yardstick for design verification, so each must be stated in a way that a test, analysis or inspection can check.
Two definitions receive special attention. Essential performance, in the sense of IEC 60601-1, names the clinical functions whose loss or degradation would cause unacceptable risk, and says how they will be observed during type testing. Basic safety requirements cover protection against physical hazards in normal use and single fault conditions. The reviewers also look at the first hazard analysis, the use specification and the list of product compliance requirements, because missing items here are the usual cause of surprises in verification.
The reviewers should also look at what is deliberately left out. Every input carries cost through verification and, later, through change control, so inputs that do not trace to a user need, a standard, a risk control or a recorded business reason are candidates for removal. For a custom chip, the review checks that chip-level requirements are derived from the signal chain budget rather than from a wish for the best possible figure, and that each carries a margin chosen on purpose. The inputs approved here also feed the electrical safety and EMC test plan, so the compliance test engineer should confirm each test-related input can be judged by a laboratory.
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