QMSR brings ISO 13485's management responsibility clauses into FDA regulation. What "top management" engagement in management review now requires, and how to show executive accountability that holds up at inspection.

How FDA's QMSR treats risk management through ISO 13485 and ISO 14971, the most common file weaknesses, and how to build a living risk management system.

How complaint handling works under the QMSR: ISO 13485 clause 8.2.2, 21 CFR 820.35 record content, Part 803 MDR timelines, Part 806, and reportability scenarios.

FDA retired QSIT, its 30-year device inspection framework, on Feb 2, 2026. Here's what the new QMSR-aligned, risk-based process means for your audits.