Maps to
FDA QMSR (Part 820): §820.30(c)
ISO 13485: ISO 13485 §7.3.3
Requirement text
Inputs relating to product requirements shall be determined and records maintained. These inputs shall include functional, performance, usability and safety requirements.
Atomic constraints
- •Inputs must include functional and performance requirements.
- •Inputs must include usability and safety requirements.
- •Records of inputs must be maintained.
- •Conflicts in requirements must be resolved.
Evidence signals
- •
FILE_EXISTS
(SRS|User Needs|Requirement)
- •
CONTENT_MATCH
Identify list of safety and usability requirements in the document.
Audit defense
Design inputs for [your product] are captured in [your document ID]. We ensure that functional and safety requirements are derived directly from our initial risk assessment (ISO 14971), preventing 'orphan requirements' that have no safety justification.