📋 Case Study

Medical Device BOM Version Control Failure at EU Class III Manufacturer

Uncontrolled BOM revisions caused nonconformance during Notified Body audit

🏗️ Project Overview

EU Class III infusion pump redesign for CE Mark renewal

🎯 Challenge

Uncontrolled BOM revisions caused nonconformance during Notified Body audit

🔧 Design Approach

Implemented dual-approval workflow (Engineering + QA), automated revision tagging, and change impact dashboards

📐 Design Diagram

AI-generated project design illustration

📐 Key Calculations

Revision Drift Index

(# of unapproved changes / # of released items) × 100

Result: 12.7%

Quantified version control breakdown

📊 Results

Zero nonconformities in next audit; 83% faster ECO closure

💡 Lessons Learned

• •Revision gates must be enforced digitally, not procedurally
• •Every BOM line item requires a traceable change history

✅ Key Takeaways

• 1Revision gates must be enforced digitally, not procedurally
• 2Every BOM line item requires a traceable change history