TUYOU Medical Imaging Co. Ltd is ISO13485:2016 certified, it covers the complete lifecycle : R&D, procurement, production &test, and after‑sales service.

1. Incoming Quality Control (IQC)

— Incoming inspection and verification of key products, e.g. image sensors, optical parts and electronic modules, to ensure that they meet specified purchase requirements before they are used in production

2. In‑process Production Control

Each production procedure must follow manufacturing operation standard(s). Semi‑finished goods are sampled and inspected to ensure the conformance of the specified requirements.

3. Finished product quality control

Every medical endoscopic camera system must pass the aging test, image performance test, and AV Output and Connectivity compliance test before packing.

4. Certificates & Regulatory Document

Except new products in sample & pre-production stage, the medical products are CE certified. With official business agreement in place, we provide other regulatory documents to facilitate product registration when needed, e.g technical construction files, risk analysis, test data, and etc.

It is the company charter to continue to improving our QC control to standard to meet the ever increasing demand on quality from our global medical partners.