QSIT Archives - QualityHub

MedCon 2026: FDA Says Medical Device Inspectorate Builds on QSIT Legacy

April 23, 2026

FDA officials at MedCon 2026 said the agency’s new medical device inspection framework under the Quality Management System Regulation builds on the legacy of the

QHub Viewpoint║After QSIT: Why the MedTech Industry Still Needs an FDA Inspection Roadmap

February 24, 2026

The FDA replaced its longstanding Quality System Regulation and QSIT inspection framework with a new QMSR rule aligned to ISO 13485, but without providing a

R.I.P. QSIT (1999-2026): A Requiem for FDA’s Inspection Technique

January 27, 2026

As the FDA prepares to retire its longstanding Quality System Inspection Technique with the rollout of the new Quality Management System Regulation, QSIT creator and