Executive Summary

Projected demand required a third manufacturing line, but limited internal engineering and validation headcount constrained execution. The client needed specialized project management and validation support to accelerate delivery while maintaining quality and regulatory compliance.

Objectives

• Increase installed manufacturing capacity
• Complete facility, equipment, software, and process validation
• Achieve production readiness for projected demand
• Support commercial launch with compliant documentation

BEPC's Role

BEPC provided PMO leadership, validation assessment, validation planning, facility coordination, preventive maintenance and calibration setup, IQ, CSV, UAT, OQ/PQ execution, station readiness, training, and process verification.

Scope & Approach

• Prepared facilities and utilities for the new line
• Supported equipment installation and station readiness
• Created preventive maintenance and calibration requirements
• Executed IQ, CSV, OQ/PQ, test reports, training, and production-readiness activities

BEPC integrated project management and validation execution so facility readiness, equipment setup, software validation, test method validation, and process qualification could move together toward release.

Outcomes

The third production line was commissioned and validated, increasing installed capacity from 288K to 432K units per year. Validation activities were completed and the line was released for production to support projected demand.

Metricas clave

• Manufacturing capacity: 432K pcs/year (+144K pcs/year (+50%))
• Production readiness: Commissioned, qualified, and production-ready (Released for demand support)
• Validation deliverables: 100% completed (Validation package closed)

Evidencia visual (descripcion)

• Electrophysiology catheter manufacturing line visual for the validated capacity expansion.
• Validation readiness visual for IQ, CSV, TMV, OQ/PQ, and PPQ execution.

Trust & References

BEPC's validation team took our third line from empty floor space to released production, and installed capacity went from 288K to 432K units a year. The PMO discipline they brought meant no surprises at any quality gate.

Ultima revision: July 2026