FAQ

Core Capabilities

What is your minimum order quantity?

We have no fixed minimum order quantity. Projects of any volume are welcome — unit pricing is simply adjusted according to order quantity.

What is your core competency?

We specialize in high-precision LSR (liquid silicone rubber) and 2K/multi-shot injection molds, flashless cold-runner tooling design, micro-molding inserts, and high-cavitation tooling for medical and high-precision technical applications.

What do you do differently than your competition?

We combine 0.5μm micro-precision machining with ISO 13485 medical standards. This delivers 30–40% cost efficiency and tooling lead times 4–6 weeks faster than Western suppliers, backed by strong DFM and engineering co-development support.

What are your key capabilities (materials, processes, tonnage range)?

We offer an ESI (Early Supplier Involvement) team active in the new-product development stage, extensive medical-industry experience, and a full understanding of ISO 13485. Our quality management system complies with both QMSR 820 and ISO 13485, and every medical project is supported by a dedicated core team to guarantee each procedure.

Is your equipment at capacity? Do you have room for our business?

Yes. We maintain dedicated production capacity and can accommodate new customer programs.

What CAD/Moldflow software do you use — can you exchange files with our formats?

We use UG NX, Pro/E (Creo), SolidWorks and Moldflow, and fully support all standard file exchanges including STEP, IGES, X_T and DWG.

Quality & Regulatory (Medical)

Do you have ISO 13485 certification?

Yes. Our ISO 13485 certification is approved by Bureau Veritas (BV), an internationally accredited body.

Do you have experience building tooling/parts for FDA-regulated devices?

Yes. We have proven experience manufacturing tooling and molded parts for FDA-regulated medical devices, and can provide project references on request.

How do you manage material traceability and lot control for medical-grade resins?

We operate a complete traceability and batch control system fully aligned with ISO 13485:2016. Every incoming lot arrives with the supplier's Certificate of Analysis (one lot, one certificate) and receives its own batch number under our Batch Number Management System (WI-QA-007). All incoming material passes IQC inspection and release per our Product Identification and Traceability Procedure (HO-2-011), with non-conforming material quarantined under our Nonconforming Control Procedure (HO-2-016). We apply First-In, First-Out (FIFO) storage and release, and each production batch is logged together with raw-material batch, machine, mold, operator and process parameters — one production batch always uses one raw-material batch. This gives 100% traceability in both directions: forward from raw material to finished product to customer, and backward from a finished product or complaint to the raw-material supplier. We run a traceability drill at least once a year, confirming we can retrieve all records of a randomly selected batch within 4 hours. Batch records are kept for one year after product shelf-life expiry, or at least 10 years, whichever is longer.

Do you support IQ/OQ/PQ mold qualification and process validation documentation?

Yes. We fully support IQ/OQ/PQ mold qualification and provide complete process validation documentation for medical projects.

What is your change-control process if a tool or process needs modification after approval?

We follow a structured six-step ECN process: (1) ECN application and approval, defining change reasons and before/after specifications with customer and Management Representative sign-off; (2) change evaluation and classification (e.g., Minor Change) covering mold feasibility, product-performance impact and affected controlled documents; (3) change verification via a small sample run and Verification Report; (4) document control and version updates; (5) training and pilot production; and (6) ECN closure and archiving of all records for full quality traceability.

Do you have cleanroom molding/assembly capability? What class?

Yes. A Class 8 (100,000) cleanroom environment is available for medical molding, assembly and packaging.

Sourcing & Compliance

How do you protect IP and handle NDAs for proprietary tooling designs?

We use strict Non-Disclosure Agreements (NDAs), encrypted server storage, role-based document access control, and physically restricted toolroom areas for proprietary customer projects.

Do you have export experience to the US for regulated products — how do you handle customs/duties?

Yes, we have extensive export experience to the US and EU. We support flexible Incoterms including EXW, FOB, DAP and DDP (door-to-door, fully cleared with duties paid via our logistics partners).

Tooling & Engineering

What steel types/mold classifications do you build for medical-grade tools?

We build to SPI Class 101 and 102 standards using premium hardened steels such as Assab S136 (HRC 48–52), 1.2083, NAK80 and H13, ensuring high corrosion resistance and long tool life of 1,000,000+ shots.

Do you provide DFM feedback before cutting steel? What is the turnaround time?

Yes. We complete the DFM report within 2–3 business days (timelines may vary slightly by product structure). Approval depends on the client — urgent feedback is often received within 2 days, also it might take up to a week depending on the client's schedule.

Production & QC

What is your first-article/sampling process — do you provide dimensional inspection reports (CMM, etc.)?

Yes. T1 samples are shipped together with full CMM dimensional inspection reports, material certificates and parameter sheets for formal customer approval.

What in-process quality controls do you use?

We use real-time monitoring with CMM, optical comparators, automated vision inspection, and SPC tracking for critical-to-quality (CTQ) dimensions during mass production.

Business & Relationship

Are you open to a third-party or customer facility audit?

Yes. We welcome both virtual tours and physical facility or quality-system audits by customers or accredited third-party auditing firms.

What is your ownership/financial structure?

We are a privately held company with stable financial status, continuous reinvestment in high-end machinery (CNC, EDM, CMM), and zero long-term liability risk.

What after-sales support do you provide — tooling maintenance, spare cavities, repairs?

Yes. We provide full after-sales support including tooling maintenance, spare cavities/wear parts, and mold repair services.