Problem Statement

Design & Development of drug eluting coronary stent and stent delivery system to reduce the occurrence of stent thrombosis

Speed to Market, Design Complexity, Novel material/technology

Compliance to internal & external standards including ISOs: 14971, 10555, 25539, 10993, FDA guidelines for stents and delivery systems

EZEN Solution

Design Evaluation, Design Characterization, Design Verification & Validation

Component Qualification & supplier qualification

Investigational testing & comparative studies per ASTM standards: D638, E8, F3067, F2477, F3067, F2942

Statistical Process Capability and Data Analysis using Minitab

Deliverables: Design Dossier, DHF, dFMEA, pFMEA, Protocols & Reports

Efficient & Optimal Resource Model

FDA & ISO Compliance

End to end Product Development Support