Company profile

  Guorui Zhongan Medical Technology Group Yangtze River Delta Headquarters organization, is a professional CRO service platform in the field of medical devices, and actively respond to the national Belt and Road policy call, in Jiangsu, Zhejiang, Shanghai and Anhui region with professional services to help enterprises compliance, enable medical device enterprises products listed at home and abroad and overseas sales, create a better future.  Our services include: Domestic and foreign clinical trial research, global regulatory registration consulting (including China NMPA, EU CEMDR&IVDR, US FDA&510K and other global mainstream and emerging market certification), product quality testing, free sales certificate application, quality management system counseling (MDSAP, ISO13485, QSR820, GMP and other international standards Certification), regulatory training and local authorized representative services (covering Europe, the Americas, Asia and other regions) to provide customers with tailor-made one-stop technical solutions to help their products enter the global market quickly and efficiently.

The technical team is strong

Technical staff accounts for more than 60%, and our technical team members have many years of industry background and rich project experience. In many important markets around the world have registered successful cases!

Self-owned subsidiary and localization team

At present, Guorui Zhongan has set up subsidiaries and localization teams in the United States, Germany, Spain, Hong Kong, Brazil, Russia, India, Indonesia, Malaysia, Vietnam, Saudi Arabia, Thailand, Guangdong, Jiangsu, Shandong, Hunan, Beijing, Hubei, Henan and Fujian.

The internal project management process is mature

Guorui Zhongan Group implements a strict project management system, each project will be assigned the corresponding project manager responsible for coordination, and will be equipped with project team members to cooperate, to ensure the smooth operation of the project and efficient completion.

Vast channel resources

Guorui Zhongan has established cooperation with more than 300 clinical centers around the world, and can conduct clinical trial research and usability research services in the United States, Europe, Southeast Asia, Africa, and China.

One-stop CRO

The core business of Guorui Zhongan includes: registration consultation + clinical trial + inspection and testing + local authorized representative + system guidance + regulatory training. Can provide one-stop market access and compliance services for medical device city enterprises!

Reasonable quotation

Make reasonable quotation evaluation based on the actual situation of the enterprise and the specific workload of the project.