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

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.

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.

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.

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

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

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

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

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.

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

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.

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

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

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).

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.

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.

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

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

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

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.

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