Transition from QSR (820) to harmonised QMSR by 2 Feb 2026.
Representative work
Device classes & artefacts we support.
QMSR PyramidQuality Metrics and KPIsDiagnostic instrumentationManagement Reviews
The problem
FDA new Quality System Regulation (QMSR) references the ISO 13485 standard as of 2016, however it includes additional aspects specific to FDA for Medical Device Reporting (MDRs), Risk Management, Complaint Handling, Design Controls, Labelling, etc.
Our solution
Implement a transition Program for QMSR: Delta Analysis; Procedure Updates; Training; Integration of FDA Requirements into all Quality Management Systems.
Process
How we run this engagement.
QSR-to-QMSR delta mapping
Procedure & form updates
Training plan & deployment
Internal audit refresher
Mock FDA inspections
Post FDA inspection support
Transition from QSR (820) to harmonised QMSR by 2 Feb 2026.
How we help
QMSR transition program: delta analysis, procedure updates, training, and integration with FDA's expectations.
