Project Overview
A medical device manufacturer required permanent marking on surgical instruments. The project demanded ISO 13485 compliance, UDI (Unique Device Identification) requirements, and biocompatibility validation.
Challenge
The primary challenges included:
- ISO 13485 Compliance: Medical device quality system requirements
- UDI Compliance: Unique Device Identification marking requirements
- Biocompatibility: ISO 10993 biocompatibility testing
- Permanence: Marking must withstand sterilization and use
- Documentation: Complete regulatory documentation
Solution
Our engineering team developed a comprehensive solution:
Medical-Grade Printing
- Biocompatible inks (ISO 10993 certified)
- Pad printing process validated for medical devices
- UDI-compliant marking format and placement
- Cleanroom printing environment (ISO Class 7)
Quality Systems
- ISO 13485 certified processes
- Device History Records for each lot
- Incoming, in-process, and final inspection
- Complete traceability
Validation
- Biocompatibility testing per ISO 10993
- Sterilization resistance validation (autoclave, EtO, gamma)
- Abrasion resistance testing
- Chemical resistance testing
Results
The project exceeded all targets:
| Metric | Target | Achieved |
|---|---|---|
| Certification | ISO 13485 | Achieved |
| UDI Compliance | Required | Verified |
| Biocompatibility | ISO 10993 | Passed |
| Annual Volume | 50K units | 100K+ units |
| FDA Audit | Pass | Pass (Zero Findings) |
Key Success Factors
- Medical Expertise: Deep understanding of regulatory requirements
- Biocompatible Materials: Medical-grade inks and processes
- Quality Systems: ISO 13485 ensuring compliance
- Documentation: Complete records for regulatory submissions
Customer Testimonial
“CoreLMould’s medical marking capabilities are exceptional. ISO 13485 certified, UDI compliant, biocompatible, and passed FDA audit. They understand medical device requirements perfectly.”
- Regulatory Affairs Director, Medical Device Manufacturer