KERCH Technology Co., ltd

1. Company & Trust

Q001: Are you a trading company or a manufacturer?
A001: Kerch Technology is a direct manufacturer with in-house mold fabrication, precision injection molding, microfluidic bonding, and cleanroom production.
Customer Value: You work directly with the factory—no middlemen, no loss of technical control.


Q002: Do you focus on medical and IVD products?
A002: Yes. Kerch specializes in microfluidic chips, IVD consumables, and precision medical device components.
Customer Value: We understand medical risk, not just plastic parts.


Q003: What quality certifications do you hold?
A003: Kerch is certified to ISO 13485 and ISO 9001:2015.
Customer Value: Your supplier already meets medical audit expectations—lower regulatory risk.


Q004: Can you support customer audits?
A004: Yes. Kerch regularly supports customer and third-party audits.
Customer Value: Audit-ready systems reduce onboarding time.


Q005: Where is your manufacturing site located?
A005: Bao’an District, Shenzhen, China.
Customer Value: Mature medical manufacturing ecosystem with fast supply-chain response.


Q006: What is the size of your factory and team?
A006: ~8,000 m² facility with ~100 employees.
Customer Value: Large enough for stability, focused enough for flexibility.


Q007: Do you work with overseas customers?
A007: Yes, Kerch serves global IVD and MedTech customers.
Customer Value: Experienced in international communication and standards.


Q008: Can you sign NDAs and protect IP?
A008: Yes, NDA and IP protection are standard.
Customer Value: Your designs stay secure during development and production.


Q009: Do you have long-term customers?
A009: Yes, many projects run for multiple years.
Customer Value: Proven long-term reliability, not short-term project hopping.


Q010: What differentiates Kerch from general injection molders?
A010: Micron-level precision + medical compliance + microfluidic know-how.
Customer Value: Most injection molders fail at microfluidics mass production—Kerch doesn’t.


2. Microfluidic & Technical Capability

Q016: What is the smallest microchannel you can achieve?
A016: ≤10 μm depending on structure and material.
Customer Value: Enables next-generation microfluidic designs, not just lab demos.


Q017: What mold accuracy can you achieve?
A017: ±1 μm.
Customer Value: Critical dimensions stay stable from prototype to mass production.


Q018: What surface roughness can you control?
A018: Ra 5–20 nm.
Customer Value: Better flow behavior and optical performance than standard tooling.


Q019: What materials do you process?
A019: PMMA, PC, PS, PP, COC, COP, PDMS, PEIetc.
Customer Value: Freedom to choose materials based on function, not supplier limits.


Q020: Do you have COC/COP mass production experience?
A020: Yes.
Customer Value: Many suppliers can sample COC—few can mass produce it stably.


Q021: Do you support PDMS chips?
A021: Yes, including hybrid solutions.
Customer Value: Smooth transition from research to scalable manufacturing.


Q022: Can you manufacture multi-layer chips?
A022: Yes, typically 2–4 layers with micron alignment.
Customer Value: Complex chip functions without assembly instability.


Q023: What bonding technologies do you offer?
A023: Thermal, molecular, adhesive bonding, Ultra-sonic
Customer Value: Bonding method selected for reliability, not convenience.


Q024: How do you ensure layer alignment?
A024: Precision fixtures and process verification.
Customer Value: Prevents channel blockage and yield loss.


Q025: What is the mold life?
A025: >200,000 cycles.
Customer Value: Lower long-term cost and stable supply.


Q026: Can you make complex 3D microstructures?
A026: Yes—V-grooves, wave channels, micro-pillars, stepped features.
Customer Value: Design freedom without manufacturability compromise.


Q027: How do you prevent microstructure deformation?
A027: Mold design + process window control.
Customer Value: Higher yield and fewer surprises during ramp-up.


Q028: Do you provide DFM feedback?
A028: Yes, early-stage manufacturability review is standard.
Customer Value: Problems are solved before tooling—not after.


Q029: Do you provide measurement reports?
A029: Yes, including microstructure measurements.
Customer Value: Objective data builds trust with R&D and QA teams.


Q030: Can you integrate chip + system?
A030: Yes, including encapsulation and assembly.
Customer Value: Fewer suppliers, fewer risks.


3. Quality, Cleanroom & Compliance

Q041: Do you operate cleanroom injection molding?
A041: Yes, Class 100,000 cleanroom.
Customer Value: Reduced contamination risk for sensitive microchannels.


Q042: Do you follow ISO 13485 processes?
A042: Yes, all medical projects follow ISO 13485.
Customer Value: Built-in compliance, not retrofitted paperwork.


Q043: Is material traceability ensured?
A043: Yes, full batch traceability.
Customer Value: Faster root cause analysis if issues occur.


Q044: Do you perform incoming inspection?
A044: Yes, mandatory IQC.
Customer Value: Problems are stopped before entering production.


Q045: Do you conduct first article inspection?
A045: Yes, every project.
Customer Value: Reduces ramp-up risk.


Q046: How do you handle deviations?
A046: Isolation, investigation, CAPA.
Customer Value: Problems are fixed systemically, not temporarily.


Q047: Do you support APQP / PPAP?
A047: Yes, on request.
Customer Value: Familiar language for automotive and regulated customers.


Q048: Do you provide 8D reports?
A048: Yes.
Customer Value: Clear accountability and structured problem solving.


Q049: How do you prevent recurring issues?
A049: Preventive actions embedded into process control.
Customer Value: Fewer repeated disruptions.


Q050: What is your quality philosophy?
A050: Traceability, stability, continuous improvement.
Customer Value: Long-term partner mindset, not short-term delivery focus.


4. Commercial & Cooperation

Q061: What is the mold lead time?
A061: Typically several weeks depending on complexity.
Customer Value: Predictable planning for project timelines.


Q062: Do you support low MOQs?
A062: Yes, especially for medical projects.
Customer Value: Lower entry barrier for new products.


Q063: Can you scale production?
A063: Yes, with forecasting alignment.
Customer Value: Growth-ready without changing suppliers.


Q064: How is pricing determined?
A064: Based on material, tooling, process complexity, and volume.
Customer Value: Transparent cost logic—no black box pricing.


Q065: Can tooling cost be amortized?
A065: Yes, negotiable.
Customer Value: Reduced upfront investment.


Q066: Do you support customized packaging?
A066: Yes, including medical-grade packaging.
Customer Value: Ready for regulatory and logistics requirements.


Q067: Do you support export documentation?
A067: Yes.
Customer Value: Smooth international shipment.


Q068: Can you support urgent orders?
A068: Subject to evaluation.
Customer Value: Flexibility when market pressure hits.


Q069: Why should customers choose Kerch?
A069: Because we understand and experience how to industrialize microfluidics.
Customer Value: Fewer failures between prototype and mass production.


Q070: One-sentence summary of Kerch?
A070: Turning microfluidic innovation into stable mass production.
Customer Value: Exactly what most microfluidic projects struggle with.




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