Project Overview
A surgical equipment company required complete manufacturing of their Class II medical device. The project demanded ISO 13485 certification, multiple component production, cleanroom assembly, and sterilization.
Challenge
The primary challenges included:
- ISO 13485 Certification: Medical device quality system requirements
- Multiple Components: 12+ molded parts per device
- Cleanroom Assembly: ISO Class 7 environment required
- Sterilization: Gamma sterilization validation and coordination
- Regulatory Compliance: FDA and international regulatory requirements
Solution
Our engineering team developed a comprehensive solution:
Manufacturing Integration
- Precision molding of all plastic components
- Cleanroom assembly cell (ISO Class 7)
- Blister packaging for sterilization
- Sterilization coordination with certified provider
Quality Systems
- ISO 13485 certified processes
- Device History Records for each lot
- Incoming, in-process, and final inspection
- Comprehensive documentation for regulatory submissions
Validation
- IQ/OQ/PQ for all critical processes
- Sterilization validation (SAL 10^-6)
- Packaging validation for shelf life
- Biocompatibility testing per ISO 10993
Results
The project exceeded all targets:
| Metric | Target | Achieved |
|---|---|---|
| Certification | ISO 13485 | Achieved |
| Annual Volume | 100K units | 200K+ units |
| Time-to-Market | 12 months | 9 months |
| Quality Escapes | 0 | 0 |
| FDA Audit | Pass | Pass (Zero Findings) |
Key Success Factors
- Medical Expertise: Deep understanding of regulatory requirements
- Complete Capability: All manufacturing steps under one roof
- Quality Systems: ISO 13485 processes ensuring compliance
- Speed: Integrated approach accelerating time-to-market
Customer Testimonial
“CoreLMould’s complete manufacturing capability reduced our time-to-market by 3 months. ISO 13485 certified, zero quality issues, and successful FDA audit. They’re a true medical manufacturing partner.”
- CEO, Surgical Equipment Company