NPI
Precise implementation of NPI transfer
NPI Assurance System
NPI is the core enabler for successful product transition from design to mass production.
Through systematic process development and validation workflows, we can significantly shorten time-to-market, reduce development costs, and ensure stability and consistency in product quality. Our experienced NPI team will engages in early-stage design reviews and proactively identify manufacturing risks through DFM analysis.
DFM Optimization
In high-demand industries such as medical devices, we have an experienced DFM team that enables us to identify potential manufacturing issues early in the design phase. We provide effective solutions through design reviews, tolerance analysis and process evaluation. We focus on DFM and mold design and fabrication to ensure efficient transition from design to mass production.
Quality and Compliance Management.
We have a complete validation system (IQ/QQ/PQ) and documentation as FDA and CE. Additionally, by establishing control limits for key process parameters and contingency plans for supply chain development, we can effectively respond to raw material fluctuations and equipment malfunctions, ensuring continuity in production.
NPI process
Project Initiation
- Project Team Formation
- Project Objectives Confirmation
- Project Plan Communication
Project Initiation
- Design Review
- Tolerance Feasibility Analysis
- Process Review
- Measurement Feasibility Analysis
- Fixture/test Equipment Evaluation
Project Initiation
- DFM Design
- Mold Design and Fabrication
- Equipment Fabrication
- Automation Review and Fabrication
- Measurement fixture Development
Project Initiation
- Mold Trial
- Automation Debugging
- Measurement Method Validation
- Packaging Validation
- IQ/OQ/PQ Validation
- VMP
Project Initiation
- Mass Production
- Project Evaluation