Design Input

The physical and performance requirements of a device that serve as the basis for its design. Design verification confirms that the design outputs meet them.

Where it is written

ISO 13485:2016 clause 7.3.3; definition as in 21 CFR 820.3(f) before February 2, 2026

Old rule

21 CFR 820.3(f) and 820.30(c), in Part 820 before February 2, 2026

Also called

design and development inputs

Related terms