ENGINEERING TO SCALE
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BUILT TO SCALE
Level 5 & Level 7 cleanrooms
Controlled environments for critical steps and high-precision assembly, built for low particle counts and predictable output.
EVO & validation discipline
Defined inputs, validated processes, and inspection gates, so performance is engineered, not hoped for.
End-to-end manufacturing software
Traceability, batch controls, and documentation that scale with volume, so every shipment is auditable.
Quality Management System
Vita Durare’s ISO 13485‑aligned Quality Management System connects engineering, manufacturing, and supply chain into a single, controlled framework.
Design History Files (DHF) and Device Master Records (DMR)
Manufacturing Execution System (MES) and ERP integration
Batch genealogy, UDI capture, and full device traceability
CAPA, change control, and supplier qualification
Traceability & Audit Readiness
Every device is traceable, auditable, and produced under validated conditions—reducing variability and accelerating time to market across global regulatory environments.
SCALE, BY DESIGN
Operational Discipline
A balanced operating model that combines:
Automation where repeatability matters
Skilled manual assembly where precision demands it
Rigorous training and competency programs
Continuous environmental monitoring and routine requalification
This approach enables reliable scale without sacrificing quality or control.
Scalable Impact
By uniting modern infrastructure with disciplined engineering and quality systems, Vita Durare reduces manufacturing variability, shortens development cycles, and supports compliant scale for high‑risk cardiovascular devices—delivering global‑grade reliability, locally.
