Living Technical Documentation Dashboard
EU MDR / FDA | MAS-p2d
Device Description
Status: AMBER — Design Changes Pending
GSPR Mapping
Status: AMBER — PMS Inputs Pending
Manufacturing Information
Status: GREEN — Complete
Risk Management File (RMF)
Status: RED — Updates Required
Clinical Evaluation File (CER)
Status: AMBER — Updates Pending
Biological Evaluation File (BER)
Status: AMBER — Updates Pending
PMS Integration
Status: AMBER — PSUR Inputs Pending
Labeling & IFU
Status: RED — Update Required
Submission Readiness
Status: AMBER — Gaps Identified