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We are the first membrane switch manufacture to attain ISO13485 in Asia and uniquely positioned to effectively support this product class.
We provide
- Control Plan
- PFMEA
- OQ (Operation Qualification): DOE Analysis.
- PQ (Performance Qualification):
3 Validations run to assure production process stability.
We provide
- Substrate: polyester or polyimide foil with lamination softness.
- Screening: AG/AGCL and Dielectrics.
- Dispensing: hydro gel and conductive adhesive.
- ISO13485 certification.
- No Change Policy.
- Class 10,000 clean room and Sterilization Control.
- QSR (Quality System Regulation) level documentation & quality standard meet FDA requirement.
- CAPA system implement (Corrective Action & Preventive Action).
- APQP (Advanced Product Quality Planning):
- Control Plan
- PFMEA
- V&V Protocol & Reports: (Verification & Validation)
- OQ (Operation Qualification): DOE Analysis.
- PQ (Performance Qualification):
3 Validations run to assure production process stability.