Each shipment includes a Certificate of Conformity confirming the goods meet the agreed specification, a packing list, a commercial invoice, and the customs documentation for export. Full lot traceability is maintained from raw material to finished part. We do not issue certificates showing measured values per lot — if your QA needs specific test data, tell us at the quotation stage and we will agree what can be provided.

 

Testing is agreed per project rather than sold off a fixed menu. Send us the test list your design verification calls for, and we will confirm which tests we run in-house, which need a partner laboratory, and what the method and acceptance criteria would be. We would rather commit to a specific test than claim a general capability.

 

We use medical-grade raw materials from qualified suppliers and can provide material certificates and full lot traceability. Where a project needs biocompatibility data, we work with your team and the material supplier on the documentation route — we do not issue ISO 10993 or USP Class VI reports ourselves.

 

Yes. We operate under an ISO 13485 quality management system, certificate valid to January 2029. Extrusion and assembly run in an ISO Class 7 cleanroom at our Suzhou facility. A copy of the certificate is available on request.