We use medical-grade silicone rubber including liquid silicone rubber (LSR), platinum-cured high-consistency rubber (HCR), and FDA-compliant silicone elastomers. All materials meet international standards such as USP Class VI, ISO 10993, RoHS, and FDA CFR 21 177.2600.

Yes. We can produce implantable silicone parts using biocompatible materials certified for short-term or long-term implantation, based on project requirements. Our facility complies with ISO 13485 for medical manufacturing.

Absolutely. Our facility includes a Class 100,000 (ISO 8) cleanroom, ideal for producing precision silicone parts for medical devices, especially those that require low particulate and contamination-free processing.

Our typical MOQ starts at 1,000 pieces, depending on the part’s complexity and size. However, we also support low-volume prototyping and pilot runs for new medical devices.

Yes. Our in-house engineering team provides DFM (Design for Manufacturing) assistance, mold design, and rapid prototyping. We help medical companies turn concepts into production-ready silicone parts.

We are ISO 9001 and ISO 13485 certified, and our materials are FDA-compliant and RoHS/REACH certified. We also support clients in generating material traceability and compliance documentation.

Yes. Our medical silicone components can be designed and produced for compatibility with ETO, gamma, and autoclave sterilization methods.