The FDA’s Quality Management System Regulation Is In Effect
Is your quality system ready for what investigators will look for?
QMSR replaced the Quality System Regulation in February 2026 and brought with it a more rigorous inspection framework, tighter record linkage requirements, and closer alignment with ISO 13485. Companies that were compliant under the old standard are not automatically compliant under the new one. The gaps are specific and the FDA is already looking for them.
MEDVACON has developed two fixed-scope, fixed-fee engagements built specifically for the QMSR environment. Each one is designed to give you a clear picture of where you stand and exactly what needs to move before an investigator walks through the door.
FDA QMSR Readiness Rehearsal
A three-week onsite engagement that tests your team’s ability to produce a complete evidence trail under inspection pressure. You leave with an inspection readiness report, an evidence map, a response playbook, and a 30-60-90 roadmap.
CAPA and Complaint Record Tracing
A five-business-day remote review of three CAPA records and three complaint records against QMSR inspection standards. You receive a scorecard, a prioritized action list, and a one-page executive summary.
Both engagements are fixed scope with no open-ended consulting hours. Pricing and timing are provided on a quick call