FAQ

1.What types of medical parts do you manufacture?

We produce precision components for diagnostic devices, surgical instruments, implantable housings, connectors, and disposable trays using CNC machining, injection molding, sheet metal, and finishing (anodizing, passivation, polishing). Materials include stainless steel, titanium, medical-grade aluminum, PEEK, PTFE, and biocompatible polymers.

2.Can you meet medical industry standards and certifications?

Yes — we manufacture to customer-required standards and can support ISO 13485/ISO 9001 processes, FDA/GMP requirements, CE marking preparation, and chemical compliance (RoHS/REACH) upon request. We also provide material certificates and process documentation to support regulatory submissions.

3.What quality control and inspection do you perform?

Quality control includes incoming material verification, in-process checks, final inspection with CMM, optical inspection, functional testing, and statistical process control (SPC). Every part can be delivered with inspection reports, material traceability, and batch/lot numbering.

4.What are your sample policy, MOQ and lead times?

We offer prototyping and low-volume samples for validation. Minimum order quantities and lead times depend on part complexity — typical sample turnaround is 1–3 weeks; production runs commonly take 3–8 weeks. Contact us with drawings for an exact MOQ and lead-time quote.

5.Do you provide design support, tooling and assembly?

Yes — we offer DFM reviews, rapid prototyping, tool-making, molding and stamping tooling, plus kitting and final assembly in controlled environments. We can also support cleanroom assembly and coordinate terminal sterilization (e.g., ETO) through approved partners if required.

6.What documentation and traceability will you supply?

We supply full traceability packages including material certificates (MTRs), inspection reports, process flow charts, device history records or device master records on request, an