A single-term, plain-language glossary compiled from the FDA documentation wiki — covering QMSR / 21 CFR Part 820, ISO 13485:2016, ISO 14971:2019, ISO 9000:2015 vocabulary, MDR / Part 803, corrections & removals / Part 806, recalls / Part 810, FDA inspections, premarket pathways, CAPA and the six QMS Areas, UDI, and enforcement. Each entry links to the wiki page it is drawn from. Use Flashcard mode to self-test instead of reading definitions directly.