On September 2, 2021, the two-day "QSR 820 System and 510K Registration Special Training in the United States" organized by the Shenzhen Medical Device Quality Management Promotion Association came to a successful conclusion at the Mindray Company Lecture Hall. This special training is jointly organized by the Shenzhen Medical Device Quality Management Promotion Association and Shenzhen Ruinni Medical Device Management Consulting Co., Ltd., with Wang Hailong, General Manager of Ruinni, as the keynote speaker!With the continuous development and growth of China's medical device industry, it is imperative for medical device enterprises to go abroad and their products to enter the global market. The United States is one of the major markets for medical device products, and the FDA is an experienced regulatory agency for medical device supervision. Its regulatory system also has very strict and detailed requirements. To assist medical device companies intending to expand into the US market and obtain permits for their medical device products to be sold in the US, the Promotion Association has hired industry experts with years of experience in FDA factory inspection cases, FDA 510K registration, and enterprise registration and listing cases to teach QSR 820 system establishment and effective operation, as well as 510K registration knowledge. The aim is to help medical device companies improve the success rate of FDA registration for their medical device products and the standardized operation of their quality management systems.The training content is rich, practical, and targeted, mainly including: FDA medical device regulatory system, differences between 21 CFR 820 and ISO 13485, FDA factory inspection, 21 CFR QSR 820 quality system regulations, 21 CFR 801 labeling, 21 CFR 807 enterprise registration and product listing for medical device manufacturers and importers, 21 CFR 830 UDI, 21 CFR 860 medical device classification program, 510K registration, etc.This training has received strong support from the president unit, Shenzhen Mindray Biomedical Electronics Co., Ltd! With a heart of gratitude and feedback, the Promotion Association cordially invites more than 60 member companies who have accompanied and supported the growth of the Promotion Association for more than 5 years to participate in free training. Participants in the training will wear masks and sit separately according to epidemic prevention and control requirements. During the training process, interactive Q&A sessions were held, and the students actively consulted with the teacher regarding the QSR820 quality management system and 510K registration issues. The teacher provided answers one by one, and the students showed a strong interest in the content of this special training and highly praised their learning.  

The thermometer is one of our company's very mature products. The application process was very smooth, taking over 3 months from submitting the materials to FDA approval. On July 22, 2021, we received a written notification with three non conformities. One of the non conformities was a manual error in the test data in the third-party test report. Regarding this non conformity, our company quickly contacted Xingzhou Electronics and requested them to conduct a retest according to FDA requirements. The customer cooperated quickly and the test report was issued within three working days. Another error is the appearance of a fever warning on the color box. The main reason for this error is that the inspection of the color box information was not done properly, and the rectification plan was changed to a high temperature warning. The third issue is the cleaning, disinfection, and poisoning methods. The auditor requires that cleaning, disinfection, and poisoning be combined together, and there are special requirements for the tools used for cleaning, disinfection, and poisoning (previously applied for 510k, FDA requires separate cleaning, disinfection, and poisoning), and it is clear whether they are used by a single patient or multiple patients. As changes in cleaning, disinfection, and poisoning methods may involve revalidation, in order to avoid revalidation, we carefully revised the wording of the cleaning, disinfection, and poisoning methods and systematically explained why the changes before and after did not affect the previous validation. In just 4 days (July 27, 2021), we completed the rectification and submitted it to the FDA. After receiving the email, the FDA had a communication regarding the use of a single patient and multiple patients. Afterwards, the FDA did not raise any other questions until September 4th when we received the FDA's approval document for the 510 (K) thermometer. The 510 (K) application has been fully recognized by the client.

Ryan Ni welcomes his housewarming celebration, thank you to SGS, Huatongwei and other friends for coming! Rui Enni Consulting has been providing services to over a hundred enterprises for 14 years. We are a professional consulting company specializing in medical device regulatory consulting, registration agency, quality management system establishment and improvement, enterprise management training and coaching, and clinical agency. We adhere to the reputation based approach to survive as a consulting institution. We grew up in the medical device industry, rooted in the medical device industry, and have a preference for the medical device industry. We are committed to the common development of professionalism, service, and reputation, focusing on the research of high standards, new regulations, and products. We not only provide agency consulting services for production enterprises, but also aim to help them cultivate professional talents. We have a good reputation in the industry! Rui Enni's new address: Guangming Jingting Building welcomes friends to come and exchange, discuss, and learn!

Shenzhen Ruienni Medical Equipment Management Consulting Co., Ltd. and Zhongshan Yufeng Medical Equipment Co., Ltd. have signed a contract for the clinical trial agency of the hemorrhoid treatment device project. Our company is responsible for the planning of the clinical trial, providing two clinical trial bases, clinical trial filing and trial follow-up, and the main researchers have published literature in provincial journals. This hemorrhoid treatment device has great innovation and improvement in technology, operation, and treatment cycle. Our clinical trial agency business has been fully launched. We welcome inquiries from medical device companies!

Shenzhen Rui Enni Medical Device Management Consulting Co., Ltd. and Shenzhen Nuobo Intelligent Manufacturing Technology Co., Ltd. have reached a cooperation consensus and signed an agreement on the international registration and system of medical device IPL photon hair removal device. Rui Enni Consulting will provide guidance on the Chinese NMPA, EU CE MDR, US FDA 510K registration and certification of Class II (IIa) medical device "IPL photon hair removal device", as well as the Chinese Medical Device Production Quality Management System Specification (GMP) for active devices, international integration system guidance for Japan JGMP, US QSR 820 and EU ISO 13485+MDR QMS, and clinical trial cooperation consulting services for IPL laser hair removal device. During this cooperation process, Rui Enni also provided services such as US company registration, American agent (US agent), production license agency, and UDI registration.Rui Enni is a professional medical device consulting enterprise in Shenzhen, Guangdong Province, which is one of the sensitive words for reputation and satisfaction. It is a professional consulting company that specializes in medical device regulation consulting, registration agency, quality management system establishment and improvement, enterprise management training and coaching, and clinical agency. It adheres to the reputation route of survival as a consulting institution! We grew up in the medical device industry, rooted in the medical device industry, and have a preference for the medical device industry. Our consulting plan will be more tailored to the actual situation of the enterprise and easier to implement and execute. Customers who have cooperated with us have unanimously praised us and established long-term consulting and agency partnerships!                       For medical device consulting services, seek advice from Ruini. We provide you with professional, systematic, comprehensive, and one-stop service enjoyment. During the contract process, Ruini can always provide you with more services and surprises!

Congratulations to Shenzhen Bairuiqi Medical Equipment Co., Ltd. for obtaining the domestic medical device registration certificate for non-invasive sleep ventilators. A non-invasive sleep ventilator is a device that can replace, control, or alter a person's normal physiological breathing, increase lung ventilation, improve respiratory function, reduce respiratory function consumption, and save cardiac reserve capacity. Mainly used in households to treat snoring, which leads to sleep apnea and hypopnea, and as a home sleep ventilator for treating chronic obstructive pulmonary disease and respiratory failure. After receiving the client's commission, our company learned the working principle of the product, familiarized ourselves with on-site operations, searched for a large number of domestic and foreign literature, maintained high communication with the client, and finally lived up to expectations and obtained domestic market approval.