QMSR Pre-Mortem: Why Envoy Medical’s Warning Letter is a Textbook Case of "Siloed Risk" Failure
QMSR Pre-Mortem: Envoy Medical just gave the industry a preview of what FDA will target in 2026.
One Warning Letter.
Two severity ratings for the same infection risk.
Seven months of uninvestigated complaints.
Not a documentation miss — a system logic failure.