Executive Summary

With cleanrooms freshly qualified, the client needed to launch full manufacturing, over 30 assembly and subassembly lines for Class II and Class III cardiovascular devices, without delaying the facility's production timeline.

Objectives

• Validate product, process, equipment, and software across 30+ lines
• Stand up the validation and QA organization for a new facility
• Launch manufacturing on the planned timeline
• Align processes with current regulations and standards

BEPC's Role

BEPC staffed and led the validation program, deploying 60+ resources across Quality Assurance, Validation Engineering, Project Management, and technical support to own product, process, equipment, and software validations.

Scope & Approach

• Product, process, equipment & software validation across 30+ lines
• QA and validation-engineering staffing for a new facility
• Project management and technical support
• Process improvements aligned to current standards

BEPC embedded a 60+ person team into the launch, running validations in parallel with line installation so qualification kept pace with the production schedule, flagging and implementing process improvements along the way.

Outcomes

The manufacturing launch was completed as planned. Beyond getting lines running, BEPC delivered several process improvements that brought operations in line with the latest regulatory updates and standards.

Metricas clave

• Assembly lines launched: 30+ (New)
• Validation resources: 60+ (Staffed)
• Launch timeline: On plan (0 slip)

Evidencia visual (descripcion)

• A validation engineer reviewing documentation at a precision assembly workstation.
• Assembly and subassembly lines installed in the qualified facility.

Trust & References

Sixty-plus BEPC resources validated product, process, equipment, and software across more than thirty lines without moving our launch date. They didn't just execute the plan — they upgraded our processes to the latest regulatory standards along the way.

Ultima revision: June 2026