R&D center

Diogene production system

Our product production systems maintain strict quality control of our product quality and production line through ISO13485 certifications through international standards audits, and comply with national regulations to meet manufacturing quality item licensing requirements for medical devices produced.

1. Production system

Designed for mass production and manufacturing of products, aseptic facilities block fine bacteria and dust in the air and enhance UV sterilization to stabilize the product production and manufacturing environment. In addition, to prevent contaminated external air from entering, the internal pressure is kept above the atmospheric pressure to maintain aseptic conditions, and the temperature and humidity are always constant, ensuring quality control and product performance.

2. Quality management system

The DIOGENE Quality Control Division implements quality control for medical device manufacturing in accordance with the Medical Device Act of the Food and Drug Administration. In addition, we strictly follow the quality control of international standards through ISO audits.

3. Packing & distribution system

DIOGENE is building a systematic production line tailored to the demands of our products and a packaging and delivery system that maintains the highest quality. From a consumer perspective, we always package and distribute our products in compliance with consumer safety, health and environmental protection standards.

4. Customer service

In addition to manufacturing molecular diagnostic reagents specializing in molecular diagnostics, DIOGENE also provides consumables, software, results analysis, and inspection exercises, from various equipment and settings required for inspection. We also operate a variety of customer support systems, from hands-on labs to theoretical training such as technical introductions.