Process overview
From strategy to surveillance.
Eight stages. End-to-end agentic. Governed by design.
A device launch lives across regulatory affairs, clinical, health economics, medical affairs, market access, and pharmacovigilance — for years. Aegis runs the whole cycle as governed agents. Humans still own every decision.
Regulatory strategy
Global Regulatory Strategy
VP RAPriya Raman
Clinical evidence
Clinical Evaluation Report
CMODr. M. Okafor
Health economics
Global Value Dossier
HEORLinnea Sato
Regulatory submission
Submission Dossier
VP RAPriya Raman
Submission Agent is assembling the dossier — clinical evidence, HEOR, design history, manufacturing, labeling — module by module against HSA, PMDA, NMPA, and TGA. Two named approvers must release before transmission.
AEGIS AGENT
Submission Agent
HUMAN CHECKPOINT
2-person release · VP RA + VP Quality
KEY ARTIFACT
Submission Dossier
GOVERNANCE HOOK
Cryptographic submission receipt
Authority review & response
Deficiency response · Approval letter
DIR RAK. Voss
MLR review
Approved Asset · MLR ID
MLR CMTE3-person sign-off
Market access
Payer Dossier · coverage agreements
VP MAJ. Tanaka
Post-market surveillance
PSUR · on-demand audit pack
CSODr. R. Engel