At the beginning of 2022, the results of the project were received - Taikang Medical Doppler Fetal Aspirator obtained FDA 510K certification approval with K number 211940.The client is a start-up medical device enterprise located in Pingshan. This project is an FDA 510K certification application submitted to the United States. The client attaches great importance to it, and after a round of comparison in the consulting circle in Shenzhen, they finally chose Rui Enni Consulting based on the recommendation of the testing laboratory and the promotion of high cost-effectiveness. At the beginning of the project, our consultant planned suitable inspection items for the client and assisted them in reviewing and providing relevant documents before the report was issued. Throughout the entire audit process, a round of supplements was made. In addition to the routine descriptive issues in the explanations, the auditors also made some audit findings and recommendations on the security report, performance report, and EMC report. At the same time, auditors pay special attention to the safety of batteries. In addition to testing reports, they also require a quality control plan for the battery production process. These issues are quite common for us, and we promptly analyzed and completed the rectification after receiving the audit findings. The FDA510K certification for the project was originally expected to be approved by the end of December 2021, but was postponed to early January 2022 due to the Double Dan Festival in the United States. Okay, let's start the new year with a beautiful outcome.

Congratulations to KWL for successfully obtaining the 510 (K) approval for wrist blood pressure monitors. The wrist blood pressure monitor went through more than two months from application to approval, and was approved after a round of rectification and improvement. Some of the supplementary content mainly involves partial revisions of third-party testing reports, software documentation, and manuals. After receiving the rectification requirements, we Notify the customer immediately to find a testing machine We will revise the report and be responsible for rectifying the remaining issues. Once the client receives the revised third-party testing report, we will immediately address it Submit all rectification materials to FDA as required. We received an email notification from the FDA regarding the approval of 510K within one month of submission.It only takes about two months from submission to approval, which is inseparable from our registered teachers' familiarity and control of the product, regulations, audit requirements, and key points.Ryan always uses expertise Our service attitude of professionalism, dedication, and high response speed helps customers quickly obtain certificates legally and compliantly, accelerate listing, and achieve economic benefits Great expansion!

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!