Medical device family

ISO 13485 lets a manufacturer keep one medical device file for a whole family instead of one per device. Grouping devices this way works only when they really share design, intended use and function, so the reasons for the grouping belong in the file.

group of medical devices manufactured by or for the same organization and having the same basic design and performance characteristics related to safety, intended use and function

ISO 13485:2016, clause 3.12