1. Requirement Analysis & Feasibility Study
- Client provides: Product type, specifications, target volume, certifications (e.g., FDA/CE)
- Injection/Mold Department evaluates:
- Structural feasibility (e.g., precision nozzle molding, waterproof design)
- Material selection ( ABS/PP, medical silicone, SUS304)
- Submit preliminary quotation & timeline
2. Design & Mold Development
- ID Design: Ergonomic appearance
- MD Design:
- 3D mold design
- Mold steel selection
- Deliver prototypes
3. Sample Testing & Certification Support
- Functional Tests:
- frequency stability, cleaning efficacy, etc
- motor lifespan, IPX7 validation, etc
- Certifications:
- Roadmap planning (e.g., CE-EMC, FDA 510k for Class II devices)
- Technical documentation: PCB schematics, BOM, MSDS
- ROHS/REACH compliance certificates
4. Pilot Run & Mass Production Prep
- Mold approval (T1 report + dimensional inspection)
- Pilot run (500-1,000pcs):
- Batch consistency check for injection parts
- Assembly line validation (e.g., water flosser pressure test)
- Finalize QC protocol (AQL levels, critical tests)
5. Mass Production & Delivery
- Full-scale production
- Quality control:
- In-process inspection (e.g., sink mark check on handles)
- Aging test for finished products
- Custom packaging: Sterile bags (for denture cleaner accessories), multilingual manuals
6. After-Sales Service
- Mold maintenance: 1 free modification (within contract period)
- Defect root cause analysis & rework
- Priority production scheduling for long-term partners