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.

QMSR replaced the QSR on February 2, 2026, incorporating ISO 13485:2016 by reference. What actually changed for device manufacturers, what stayed the same, and what FDA investigators are finding in the first months of inspections.

The Medical Device Single Audit Program promises one audit that satisfies multiple regulators. How MDSAP works in 2026, what changed with QMSR and the program's new governance, and how quality teams can prepare for an audit designed to find more than a standard ISO 13485 certification would.

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.

A clause-by-clause comparison of QSR 820.30 and ISO 13485 clause 7.3 under FDA's QMSR, with terminology changes, inspection focus areas and a transition checklist.

What FDA requires for cyber devices under Section 524B: the cyber device definition, SBOMs, threat models, testing, postmarket plans and the February 2026 guidance update.

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.

In February 2008, hospitals across the United States began seeing something that almost never happens with heparin, a blood thinner used in millions of procedures every year: patients going into sudden, severe allergic-type reactions — hypotension, nausea, shortness of breath — within minutes of receiving it. The FDA would eventually trace the cause to a contaminant called oversulfated chondroitin sulfate, added somewhere upstream in the crude heparin supply chain in China, a

For thirty years, "checking MAUDE" has been shorthand for post-market vigilance in the medical device industry. It is the database regulatory teams cite in literature searches, the tool clinical affairs pulls up before a submission, the first stop for anyone trying to understand how a device is behaving once it leaves the controlled world of a clinical trial and enters the far messier world of actual patients. By the end of May 2026, it will not exist in its current form.

Five months into FDA's new Quality Management System Regulation, the agency has said out loud what's actually showing up in QMSR Form 483 findings — and it's not a paperwork problem.