GLOSSARYGlobal

Design Transfer

The documented process that translates approved design outputs into production specifications, so that the device can be manufactured as designed.

Where it is written: ISO 13485:2016 clause 7.3.8; definition as in 21 CFR 820.30(h) before February 2, 2026
Old rule: 21 CFR 820.30(h), in Part 820 before February 2, 2026
Also called: design and development transfer