User need
What the user and the intended use need, in the user's words; medical design control validates it against the finished device.
- where it sits
- the top of the chain (validated against the need, not verified)
- read from
- a level or type cell reading “user need”, “user needs”, “user requirement”, “user requirements”, “un”, “clinical need” and “intended use”; or an ID starting UN, UNR and UND, said so on the line
- standards that use it
- ISO 13485, FDA QMSR and IEC 62304
A requirement at this level is the top of its chain: it has no parent by design, is never asked for one, and carries validation rather than verification. Where a validation column is pasted, a blank cell raises finding 9.
Clauses that turn on this level
- 1 Requirement with no parent: Automotive SPICE SYS.2.BP5
- 2 No verification method or no linked verification: Automotive SPICE SYS.5.BP4
- 3 Verification failed, blocked or not run: Automotive SPICE SYS.5.BP3
- 7 Parent outside this export, or an ID used twice: Automotive SPICE SYS.2.BP5 and Automotive SPICE SYS.3.BP4