Component

Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly that is intended to be included as part of the finished, packaged, and labeled device.

Source

21 CFR § 820.3

Scoping language

The definitions in ISO 13485 and in Clause 3 of ISO 9000 (incorporated by reference, see 820.7) apply to this part, except as specified in paragraph of this section, and do not affect the meaning of similar terms defined in this title.