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Projects

Case Studies

Explore real projects with measurable outcomes across regulated operations and critical environments, with clear scope, context, and results in every case study.

Featured Case Study

Commissioning a 162,000 sq ft medical-device cleanroom facility

BEPC led the risk-based commissioning and qualification of a refurbished 162,000 sq ft facility, including 85,000 sq ft of ISO Class 8 cleanrooms, turning over a safe, validated environment ready for medical-device manufacturing.

Industry
Medical Device Manufacturing
Service
Commissioning & Qualification
Geography
Ciudad Juárez, Mexico
162,000SQ FT
Facility commissioned
85,000SQ FT
ISO Class 8 cleanroom
$40M
Total project value

a global medical-device manufacturer

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Commissioning a 162,000 sq ft medical-device cleanroom facility

Top outcomes

  • 01Production-ready controlled environment
  • 02Facilities, mechanical & utilities released
  • 03Commissioning of a $40M investment

Project library

Showing 23 of 23

Launching 30+ assembly lines for cardiovascular medical devices

Launch & TransferCardiovascular Medical Devices

Launching 30+ assembly lines for cardiovascular medical devices

60+

Validation resources deployed

  • Class II & III cardiovascular production
  • QA, validation eng., PM & technical support

a Class II/III cardiovascular device manufacturer

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Automating leak testing with a validated collaborative robot

ValidationMedical Device Manufacturing

Automating leak testing with a validated collaborative robot

50%

Workstation workload reduced

  • Operators freed from repetitive testing
  • Consistent quality segregation

an absorbable-device manufacturing line

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Replicating US suture manufacturing across a global supply chain

Launch & TransferSurgical Sutures / Medical Devices

Replicating US suture manufacturing across a global supply chain

4

Countries coordinated

  • El Paso, Germany, Italy, China
  • Proven process, new geography

a global suture manufacturer

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Turning reactive IT refresh into a proactive 600-site program

InfrastructureEnterprise IT / Telecom

Turning reactive IT refresh into a proactive 600-site program

600+

Sites managed globally

  • Single coordinated program
  • End-of-life handled before failure

a global enterprise IT organization

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Expanding onsite nitrogen generation to cut manufacturing costs

FacilitiesMedical Device Manufacturing

Expanding onsite nitrogen generation to cut manufacturing costs

$3.2M

Annual operating-cost reduction after expansion

  • Improved manufacturing cost structure
  • Lower logistics dependency and supply risk

a medical-device manufacturer

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Building a centralized supplier audit scheduling system

Supplier QualityMedical Devices / Life Sciences

Building a centralized supplier audit scheduling system

18,000 rows

Manual spreadsheet process replaced

  • Reduced version conflicts and reconciliation errors
  • Lower compliance and reporting risk

a global life-sciences manufacturer

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Migrating a production IVU monitoring system without manufacturing disruption

InfrastructureMedical Devices / Healthcare Manufacturing

Migrating a production IVU monitoring system without manufacturing disruption

0

Production interruptions during migration

  • Protected manufacturing operations during transition
  • Reduced operational risk

a medical-device manufacturing site

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Preparing an Enlabel V24 upgrade for regulated manufacturing

InfrastructureMedical Devices

Preparing an Enlabel V24 upgrade for regulated manufacturing

100%

QA-environment testing completed

  • Established readiness before production implementation
  • Reduced production cutover risk

a regulated medical-device manufacturing site

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Validating an electrophysiology catheter line to increase capacity

ValidationMedical Devices - Cardiovascular

Validating an electrophysiology catheter line to increase capacity

50%

Increase in installed manufacturing capacity

  • Supports projected demand and growth
  • Enables scalable commercial production

a global cardiovascular medical-device manufacturer

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Transferring sports-medicine manufacturing from Switzerland to Juárez

Launch & TransferMedical Devices

Transferring sports-medicine manufacturing from Switzerland to Juárez

59 SKUs

Final part numbers launched into production

  • Expanded the manufacturing footprint
  • Supported validation and production activities

a global sports-medicine device manufacturer

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Validating a SCADA migration for manufacturing operations

ValidationMedical Device Manufacturing

Validating a SCADA migration for manufacturing operations

0

Production continuity interruptions during migration

  • Protected validated manufacturing operations
  • Improves long-term architecture alignment

a global medical-device manufacturer

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Designing an AI-native PMO operating model

Software & AIData Centers & Networking / Industrial Technology

Designing an AI-native PMO operating model

92%

Labor reduction demonstrated for manual PERM screening

  • Shows measurable automation potential
  • Moves PMs faster from intake to decisions

an industrial technology enterprise

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Delivering a $60M biotechnology manufacturing facility

FacilitiesBiotechnology / Medical Device

Delivering a $60M biotechnology manufacturing facility

$60M

Manufacturing facility delivered

  • Expanded capacity and supported business growth
  • Protected capital investment and launch timeline

a global biotechnology and medical-device manufacturer

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Engineering an NPI line conversion from Varipulse to Isopulse

Launch & TransferMedical Devices

Engineering an NPI line conversion from Varipulse to Isopulse

$7.5M

Annual revenue enabled through manufacturing readiness

  • Connects engineering readiness to business value
  • Supports launch continuity and asset utilization

a multi-class MedTech device manufacturer

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Building a global supplier-audit compliance partnership

Supplier QualityMedical Devices / Pharma

Building a global supplier-audit compliance partnership

Global

Supplier audit process harmonized across regions

  • Improves communication and process control
  • Supports compliant audit execution

regulated medical-device and pharma organizations

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Creating a pre-audit coordination process across global divisions

Supplier QualityMedical Devices / Pharma

Creating a pre-audit coordination process across global divisions

PAF

Pre-Audit Form process established

  • Clarifies standards and audit scope before execution
  • Improves visibility across customer organizations

regulated medical-device and pharma organizations

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Supporting supplier-audit response and corrective action follow-up

Supplier QualityMedical Devices / Pharma

Supporting supplier-audit response and corrective action follow-up

SAR

Supplier Audit Response process defined

  • Helps corrective actions move toward closure
  • Improves consistency in supplier CAPA follow-up

regulated medical-device and pharma organizations

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Improving takt time 12% in a 50-engineer smart-factory (4IR) program

Software & AIRegulated Manufacturing

Improving takt time 12% in a 50-engineer smart-factory (4IR) program

50 engineers

Deployed across the program

  • More output from the same installed capacity
  • Growth absorbed without new lines

a global manufacturer pursuing smart-factory certification

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Stabilizing quality lab operations with 53 specialized hires

ValidationLife Sciences Quality Labs

Stabilizing quality lab operations with 53 specialized hires

53 hires

QA techs & lab analysts placed

  • Stable QA and lab shift coverage
  • Client retained proven performers permanently

a regulated manufacturer's quality and laboratory organization

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Rapid light industrial staffing for COVID-19 diagnostics manufacturing

Launch & TransferMedical Device Manufacturing

Rapid light industrial staffing for COVID-19 diagnostics manufacturing

55%

Hiring conversion rate

  • Localized event + immediate decisioning increased close rate
  • Dedicated event model compressed recruiting cycle time

a Fortune 500 medical device and nutrition manufacturer

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Hiring event for print shop operators

ValidationLight Industrial / Print Shop Operations

Hiring event for print shop operators

50%

Interview conversion (10 attendees to 5 interviews)

  • Walk-in event format increased candidate commitment
  • On-site team compressed decision latency

a Fortune 50 medical device manufacturer

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Validated global supplier audit compliance partnership

Supplier QualityMedical Devices / Pharma

Validated global supplier audit compliance partnership

20+ standards

Customer, regulatory, and international standards covered

  • Each record tracks supplier profile, QMS audit record, supplier ID, location, region, supplier type, criticality, and audit type
  • Audits executed against customer, FDA, ISO, MDSAP, EU MDR, and regional requirements

multiple regulated customer organizations and their supplier networks

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