Definition
The U.S. FDA regulatory requirements for the medical equipment quality system; the compliance course for DBS improvements must meet the external constraints first.
In detail
QSR is the U.S. FDA's Quality System Regulation requirement for medical device manufacturers, effectively a mandatory quality threshold for entering the U.S. market. In the DBS Kaizen system, it is an external constraint: any Kaizen activity must be carried out on the premise of meeting QSR, otherwise the Kaizen results may not be recognized. From 2026-02-02, the FDA has replaced QSR with QMSR; the new version 21 CFR 820 incorporates ISO 13485:2016 by reference; this course (2009) covers the rules of the QSR era, and the contrast "different from ISO 13485" no longer holds. Typical outputs are compliance checklists, audit preparation documents, and necessary Corrective Action records.
Example in practice
A medical device factory planned to introduce lean production, but management was concerned that improvement activities might affect QSR compliance. At this point, a gap analysis against QSR clauses was needed to clarify which improvement actions (e.g., process changes, equipment adjustments) required change control procedures, ensuring improvements did not deviate from regulatory requirements. After completion, a compliance assessment report was formed as the entry basis for improvement projects.