Wearable Thermometer(CE Class 2a)
Wearable ECG(CE Class 2a)
Continuous Glucose Monitor(FDA/CFDA class 3)
Implantable Hearing Aid Devices( CFDA Class 3)
Patient Monitor(FDA Class 2)
ECGs (CFDA Class 2)
Handheld Monitor Devices(FDA Class 2)
Endoscopy(FDA Class2)
Handheld Ultrasound( FDA Class 2)
Surgical Devices(CFDA Class 2, CE Class 2a)
Peritoneal Dialysis Device(CFDA Class 2)
Electronic, mechanical, software design
Prototype build
Verifications and support to validation activities
ISO 13485 compliance process and regulatory submission support
Build international quality management system
ISO13485 compliance EMS manufacturing
SCM management
Value engineering
Quality assure and traceability
Technical document and DHF
Assist type testing preparation and provide technical support
Assist to product registration process
ISO13485 compliance EMS manufacturing
SCM management
Value engineering
Quality assure and traceability
Technical document and DHF
Assist type testing preparation and provide technical support
Assist to product registration process
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Collaboration models |
Product |
Cost |
New product |
Manufacturing |
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IP ownership |
customer |
customer |
customer |
customer |
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