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Medical devices are classified as Class I, Class II and Class III. According to the Regulations for the Supervision and Administration of Medical Devices, the state classifies medical devices according to their risk level.
6S management is a management model that consists of six main sections: organisation (SEIRI), tidying (SEITION), cleaning (SEISO), cleanliness (SEIKETSU), literacy (SEIKETSU) and safety (SECURITY).
Polymer materials are closely related to our daily lives. The items we use every day such as milk tea paper cups, mobile phones and computers are all made of polymer materials, and with the development of science and technology many new materials are needed to meet our needs.
On July 13, 2022 "Creators China" Yiwu good project innovation and entrepreneurship competition for small and medium-sized enterprises was officially held
In order to further improve the quality of staff skills, guarantee the quality of products and enhance the core competitiveness, in line with the business philosophy of "quality first", Zhejiang Zhongzhi Medical Technology Co.
On the morning of July 8, the technology transfer and strategic cooperation agreement signing ceremony of CNNC and Construction International - ZhongZai Medical Technology was successfully held, and both parties announced that they would carry out deep strategic cooperation in medical device related research and other fields.
On July 1, 2022, our company held a postdoctoral workstation opening report meeting of Zhejiang Zhongzhi Medical Technology Co.
Warmly celebrate the 101st anniversary of the party establishing and the 25th anniversary of Hong Kong's return!
ZhongZai Learning Club|CE Certification Process-"Introduction to CE Certification for Medical Devices in the EU“1. according to the EU MDR , brief exposure (60 minutes), short-term exposure (60 minutes - 30 days), long-term exposure (more than 30 days).2. under the EU MDR regulation, medical devices are mainly divided into four categories: Ⅰ, Ⅱa, Ⅱb, Ⅲ.3. different certification paths are available according to different product categories.4. CE certification requires a European representative and application to the notified body for CE certification.5. Before certification, all work on product performance studies and verification must be completed, and the requirements of the regulations to prepare CE technical documentation.6. need to improve the quality management system in accordance with the requirements of the MDR regulations before certification.Group learning experience sharing.1. on the ce certification process, the key process lies in the purpose of obtaining certification, according to different purposes to choose different announcement bodies, because different announcement bodies assessment capabilities and assessment process is not consistent, the speed and ease of obtaining certification is not the same. For example, the sales region is Southeast Asia or some less developed regions of Europe, you can choose some less well-known, cost-effective announcement agencies for review, such as sales in economically developed regions of Europe, you need to choose a higher visibility, competitive announcement agencies.2. The classification of medical devices in these three certification methods are different, so the R & D team needs to be based on their own product classification and according to the requirements of registration and certification to further improve the information, any registration process need to learn and follow the requirements to do so to continuously improve their level.3. CE certification process and overview, is the first contact and understanding, this class learned the classification of medical devices and different standards in different countries, but also learned the refinement of medical devices under different classifications.Message from the Principal:Apply what you learn, transform what you learn into your own behavior, improve your skills, implement them into your work, and ultimately improve your personal income with the amoeba way of thinking about business.
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