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德國Curetis AG   
專注于一個普遍的分子診斷解決方案的開發(fā)，制造和商業(yè)化，易于使用，快速和可靠的分子疾病檢測的分子診斷公司。

Curetis AG is a molecular diagnostics company focusing on the development, manufacturing and commercialization of a universal molecular diagnostics solution for easy-to-use, fast and reliable molecular disease testing.

Curetis combines molecular biology, medical technology, diagnostics expertise and system engineering to automate molecular testing at the point of need, initially for the rapid identification of bacteria and antibiotic resistances associated with severe acute infections. The company’s comprehensive Unyvero? solution delivers clinically relevant answers in only a few hours and sets a new benchmark in molecular testing for life-threatening infectious diseases. The first product is for the rapid diagnosis of pneumonia. However, the Unyvero? solution allows for the expansion into many other important clinical applications, even for opportunities beyond infectious diseases.

Set-up to target global markets

Curetis is headquartered in Holzgerlingen, Germany, and has a large manufacturing floor in Bodelshausen. Both sites are close to Stuttgart and its international airport. The company currently has 38 employees with comprehensive expertise in the medical device and diagnostics industry, e.g. Abbott, Agilent Technologies, Beckman Coulter, Epigenomics, Hewlett Packard and Philips Medical Systems. Curetis′ team has exceptional strengths in defining and developing complete solutions for all steps required for creating new products and keeping them at the forefront of its field.

With a team of seasoned hardware and software engineers, technical biologists, physicians, marketing experts, supply chain and manufacturing specialists as well as experienced Q&A and regulatory managers, Curetis is well prepared to target the global IVD market. The team's expertise covers the entire product development process - from the identification of clinically relevant measurements through product specification and design to manufacturing, marketing and commercialization. The cross-functional team works closely with Curetis' commercial, clinical and academic partners to best fulfill its customer needs.

Quality first

To meet the company’s high quality criteria for its consumables, Curetis decided to build and operate its own production facility in Germany. This ensures full control over the manufacturing processes and the parameters for the resulting products. In addition, Curetis has implemented and maintains an ISO 13485 certified quality management system.

The certificate proves the successful implementation and use of a quality management system, which conforms to the highest international quality management standard for medical devices, including in-vitro diagnostic (IVD) products. This demonstrates Curetis’ commitment to quality and to developing safe and effective diagnostics products.