Mock FDA inspections, Notified Body audits, CAPA closure.
Representative work
Device classes & artefacts we support.
Reviewing metrics in clean roomQuality ManualDiagnostic instrumentationQMSR Pyramid
The problem
One deficiency notice from a single FDA inspection can push back your product release date by eighteen months. The FDA also issues many Warning Letters related to ineffective Corrective Actions and Preventative Actions (CAPAs).
Our solution
We lead Mock Inspections; Rebuild of CAPA Systems; Authoring responses to FDA 483/WL Notices.
Process
How we run this engagement.
QMSR / MDSAP-style mock inspection
Gap closure prioritization
CAPA system upgrade or redesign
Effectiveness verification / monitoring
Front-room / back-room training
Mock FDA inspections, Notified Body audits, CAPA closure.
How we help
Mock inspections, CAPA system rebuilds, and 483 / Warning Letter response authoring.
