Project Overview
A medical device company required complete assembly of surgical instruments. The project demanded ISO 13485 certification, cleanroom assembly environment, and comprehensive device history records for regulatory compliance.
Challenge
The primary challenges included:
- ISO 13485 Certification: Medical device quality system requirements
- Cleanroom Assembly: ISO Class 7 cleanroom environment
- Documentation: Complete Device History Records (DHR)
- Traceability: Full lot traceability from components to finished devices
- Sterilization: Validation of sterilization processes
Solution
Our engineering team developed a comprehensive solution:
Quality System
- ISO 13485 certified assembly processes
- Cleanroom assembly cell (ISO Class 7)
- Comprehensive DHR documentation system
- Lot traceability with unique identifiers
Assembly Process
- Trained and certified assembly technicians
- Standardized work instructions with visual aids
- In-process inspection at each assembly step
- Final inspection and functional testing
Documentation
- Device History Records for each lot
- Component certificates of conformity
- Assembly process records
- Inspection and test results
Results
The project exceeded all targets:
| Metric | Target | Achieved |
|---|---|---|
| Certification | ISO 13485 | Achieved |
| Annual Volume | 50K units | 100K+ units |
| Quality Escapes | 0 | 0 |
| Audit Results | Pass | Pass (Zero Findings) |
| Documentation Accuracy | 99% | 100% |
Key Success Factors
- Medical Expertise: Deep understanding of ISO 13485 requirements
- Cleanroom Capability: Proper environment for medical device assembly
- Documentation Rigor: Comprehensive records meeting regulatory standards
- Quality Culture: Zero-defect mindset throughout organization
Customer Testimonial
“CoreLMould’s ISO 13485 assembly capabilities are exceptional. They’ve delivered 100K+ surgical instruments with perfect documentation and zero quality issues. Their regulatory compliance is impressive.”
- Quality Director, Medical Device Company