Precision Medicine · Life Support
Traceable and verifiable high-reliability electronics manufacturing for medical and life science devices
Scenario Map
Industry Focus
ISO13485-compliant high-reliability electronics manufacturing and productization services, providing a solid foundation for diagnostic, therapeutic, life science, and medical-grade devices
01Industry Challenges
Industry Challenges
- 01High demands on quality traceability and documentation integrity
- 02Frequent design changes during R&D requiring rapid iteration
- 03Low volume combined with high reliability requirements
- 04Strict confidentiality for customer and product information
02Electronic Subsystems
Electronic Components Manufactured by Ledge
- 01IVD equipment control boards
- 02Medical imaging signal acquisition boards
- 03Vital sign monitoring modules
- 04Medical-grade wearable core boards
- 05Automated inspection equipment control and interface boards
03Relevant Capabilities
Key Processes & Certifications
- 01ISO13485 Medical Device Quality Management
- 02Test system development
- 03DFM and NPI
- 04Full batch traceability
- 05Low-volume flexible manufacturing