Maps to
FDA QMSR (Part 820): §820.30(b)
ISO 13485: ISO 13485 §7.3.2
Requirement text
The organization shall document design and development planning. As development progresses, planning shall be documented and updated as appropriate.
Atomic constraints
- •Planning must be documented.
- •Planning must be updated as development progresses.
- •Resources and responsibilities must be defined.
Evidence signals
- •
FILE_EXISTS
Design.*Plan
- •
CONTENT_MATCH
Does this document define specific milestones and responsible parties for design activities?
Audit defense
Our Design and Development Plan (Doc ID: [your document ID]) acts as the central roadmap for [your product]. It defines the sequence of activities and assigns roles (e.g., Quality vs. Engineering) to ensure independent oversight from day one.