QMSR inspections: how FDA inspects medical device manufacturers now

Add Your Heading Text Here Reference guide for quality and regulatory teams QMSR inspections: how FDA inspects medical device manufacturers now. On February 2, 2026, Part 820 became the Quality Management System Regulation (QMSR) and the inspection technique FDA had used for decades was withdrawn on the same day. The requirements barely moved. The way […]

Glossary – Use Case

A use case describes how a user interacts with a system to reach a goal, including alternate paths. Definition, structure, and how it differs from a user story.