Contract Manufacting Services
Contract Manufacturing: Device assembly, Injection/Molding, Sterilization and Material consulting.
Details
Medical Device Cable:
- Customized cable
- In-house HF Voltage test
ODM:
- Fast Prototyping
- 3D drawing
- DFM, V&V for medical device
- Product Improvement/Study
Primary Competitive Advantages
- Quality control
- Packaging Inspection
- Cleanroom control
- Immediate service
QC
IQC:
- Raw material from Taiwan supplier/ manufacturer
- IQC inspection
- Qualified supplier
IPQC:
- Injection, Moulding, Soldering, Assembly…
- IPQC for each process
- ISO 8 cleanroom
- USP1116 Microbiological control
- ISO14644-14 Air Quality
- Cleanliness & Sterilization
- ISO 11135 Sterilization Validation
- ISO 11737 Bio-burden
FQC/OQC:
- Final conduction test
- 100% HIPOT test
- EN 868 Packaging test
- US FDA approved sterilization plant
- BI/CI indicator and test
R & D
1. Discussion:
- Product Spec
- Packaging
- Smoke Evac. Plan
- Lap. Instrument Plan
- Private Label
2. Confirm Inquiry:
- Proposal
- Trial
3. Cooperation:
- Sales contract
- NDA
4. Registration:
- Application process
5. Distribution:
- Shipment schedule
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