A certain limited liability company in Ningbo was established in January 2002, specializing in the research and production of motors, carpet cleaning machines, personal care appliances, and home health care appliances. Its products are mainly targeted at the European and American markets and have passed UL, CE, CCC and other certifications, meeting the requirements of the EU ROHS and REACH directives. It is one of the top ten vacuum cleaner export enterprises in China, a green factory in Zhejiang Province, a hidden champion cultivation enterprise in Zhejiang Province, a single champion cultivation enterprise in Zhejiang Province, a major excellent enterprise in Ningbo City, a foreign trade strength and benefit enterprise in Ningbo City, and a comprehensive top 20 industrial enterprise per mu benefit leader in Ningbo City.Ryan Ni's coaching for the Canadian and American MDSAP certification of the company's LED phototherapy mask lasted for a total of 6 months. Wishing the enterprise a prosperous business!!

Shenzhen A Technology Co., Ltd. is a leading supplier of household medical devices in China, specializing in the research and development, production, sales, and service of portable medical devices for home use. The company adheres to people-oriented, continuous innovation, and open cooperation, and has built a solution advantage from R&D to sales in the fields of electronic blood pressure monitors, infrared thermometers, blood glucose meters, nebulizers, etc. It provides competitive solutions, products, and services for the OTC market, distributors, and end consumers, and is committed to making greater contributions to improving human health and quality of life.Rui Enni helped the company obtain the CE MDR certification for its blood pressure monitor products, which is also the 13th CE MDR certificate obtained by Rui Enni. It took a total of 18 months. I also wish the enterprise prosperity and development!!

A certain medical company was established in 2011 and has been continuously awarded the titles of Guangdong Province High tech Enterprise and "Gazelle Enterprise", the third batch of specialized and innovative "Little Giant" enterprises by the Ministry of Industry and Information Technology, and a listed hearing aid company. As a globally renowned hearing aid brand, a medical company has always pursued excellence and innovation, and its products have won major international awards such as the German Red Dot Design Award.The company focuses on the research, development, production and sales of hearing aids. Since its establishment, a medical company has obtained FDA, EU CE certification, and IS013485 medical device quality management system certificate. It has successively established cooperation relations with the leading European healthy life brand Bolle Germany, and the well-known Japanese TV shopping company Green Oak, and entered the sales channels of international chain retail enterprises such as Wal Mart, Carrefour, CVS. In 2020, a medical company established a subsidiary called Xinhailing to conduct research, development, and design work on digital hearing aid chips, becoming the first hearing aid enterprise in China to have independent chips and algorithms. In 2021, a certain medical company landed on the Beijing Stock Exchange, becoming the first listed company in China's hearing aid industry.A certain medical sales channel covers over 90 countries and regions including Europe, America, and Asia, providing hearing products and services to millions of users worldwide. A certain medical institution is committed to becoming a leader in both domestic and international markets, gradually expanding its development direction to the Chinese market, and contributing its efforts to bid farewell to the silent world for people with hearing impairments worldwide.This time, Rui Enni helped the company obtain the EU CE MDR certificate for both analog and digital hearing aids, which took 17 months; Rui Enni has also received a thank-you letter from the company! This is also the 12th CE MDR certificate obtained with the assistance of Ruini. Here, Ryan Ni wishes the enterprise a long and prosperous development!!    

Basic introduction of enteral nutrition pump:In the European Union, it belongs to Class IIa medical devices and products need to comply with the requirements of MDR regulations for medical devices.Enteral nutrition pump delivers formula nutrient solution to the patient's digestive tract through a rotating peristaltic pump or linear peristaltic pump system, providing nutrition for those who cannot take food orally. The nutrition pump includes a graphical interface that guides users to set the feed rate, volume, and other feed options for the feed pump.  The enteral nutrition pump usually consists of the following parts (but not limited to):Power supply system: provides working power for the enteral nutrition pump.Control system: It is the core unit for intelligent control and management of enteral nutrition pumps, processing detection signals and issuing instructions based on the results.Infusion execution unit: generates positive pressure on the input pipeline, pushing and controlling the flow of nutrient solution into the patient's body.L detection unit: processes the detected signal and transmits it to the control system.Alarm unit: responds to the alarm instructions issued by the control system and emits sound and light alarms.Human computer interaction unit: including input device and display device, convenient for medical personnel to operate.Shell structure: As the installation carrier and external protection for various systems, it provides necessary isolation and protection measuresAdvantages:Control infusion speed: The enteral nutrition pump can control the infusion speed of nutrient solution, ensuring that patients receive stable and uniform nutritional support. This is particularly important for patients who need to strictly control the speed and amount of nutrient intake.Timed and Quantitative Supply: Through preset parameters, the enteral nutrition pump can supply nutrient solution in a timed and quantitative manner, avoiding the complexity and errors of manual operation, and improving the efficiency and accuracy of nutritional support.Improving nutrient absorption efficiency: The enteral nutrition pump can continuously and evenly deliver nutrient solution, allowing the nutrient solution to flow into the small intestine at a constant speed with gastrointestinal peristalsis, which is beneficial for intestinal absorption and utilization, and improves nutrient absorption efficiency.Reduce complications: The use of enteral nutrition pumps can reduce complications caused by improper nutritional support, such as reflux, aspiration, diarrhea, etc. At the same time, it can also protect the gastric mucosal barrier and reduce adverse reactions in the gastrointestinal tract.Success Experience Sharing:The enteral nutrition pump applied for this time is our company's first nutrition pump to obtain CE certification. After two rounds of rectification since the CE document was submitted in March 2023, it meets all the requirements proposed by the auditor, which is another breakthrough in the field of CE certification for our company.Familiarity with regulatory and standard requirements, implementing various requirements into documents, effectively communicating with auditors, and understanding their ideas are key to obtaining CE certification.Choosing a consulting company that is proficient in both product technology and relevant regulatory standards is the key to quickly obtaining a CE certificate. Rui Enni has very mature experience in the field of CE certification, and this CE MDR certificate is already the 11th one.

A certain enterprise in Shenzhen is a medical device manufacturer that integrates research and development with production. The company focuses on innovation and research and development of low-frequency therapeutic devices (TENS and EMS). After years of unremitting research and exploration, several series of low-frequency therapeutic devices have been developed. Such as wired, rechargeable, wireless, remote control, Bluetooth connected, and low-frequency therapy devices with heating function.This time, we have launched a UKCA registration/system counseling cooperation with Ruini for our low-frequency therapeutic device and successfully obtained the certificate.

Rui Enni helps a company in Dongguan obtain FDA 510k registration for ultrasonic atomizer In February 2023, Rui Enni submitted a 510 (k) application for an atomizer, and after efforts, it finally passed the FDA review at the end of November and obtained the US market qualification. In recent years, there have been very few records of nebulizers approved by the FDA. The entire respiratory therapy series of products has received special attention from the FDA, with very strict evaluation standards that make it difficult for consulting firms and manufacturers to handle.   Below is a brief sharing of the problems and experiences encountered during the application process.1. Applicable standards for 510k: Number Category Standard Number 1 Electrical safety IEC 60601-1 2 Electromagnetic Compatibility IEC   60601-1-2 3 software IEC 62304 4 Household Electrical Safety IEC 60601-1-11 5 risk ISO 14971&   ISO TR24971 6 Biocompatibility ISO 10993 series standards (depending on actual testing projects) 7 Gas path biocompatibility ISO   18562-1/-2/-3 8 Cleaning/Disinfection FDA Medical Device Reprocessing Guidelines and Corresponding Standards 9 Particle characteristics FDA Nebulizer Guidelines, United States Pharmacopeia 10 performance standard ISO 27427   2. Biocompatibility requirementsBased on nebulizers, drugs are atomized and deposited into the respiratory tract or lungs through respiration. The biocompatibility of drug pathways such as medication cups, masks, and hoses is classified as permanent (>30 days) external access devices that come into contact with tissues. Therefore, its biocompatibility requirements are high, and in addition to the basic three items, more biocompatibility tests need to be conducted according to the requirements of Table A.1 of ISO 10993-1. Alternatively, chemical characterization and toxicological evaluation can be used instead of partial testing, such as chronic toxicity and genetic toxicity. Special attention should be paid to achieving exhaustive extraction in the testing of chemical characterization, and multiple standard substances should be selected for quantitative analysis in the analysis of organic compounds.3. Biocompatibility requirements for respiratory pathwaysThe atomizer still has a gas pathway, so it needs to be tested according to the ISO 18562 series standards based on the actual situation. In the process of conducting these tests, the main issues are that the testing conditions and methods should be clear and complete, and the results should be as detailed as possible. For example, VOC testing should ensure that it reaches a stable state or is below the allowable intake, and the worst-case exposure within the expected lifespan should be considered during the testing process.4. Characteristics of atomized particlesThe aerosol performance testing of nebulizers is also a key focus of FDA attention. According to the FDA's guidelines for nebulizer evaluation, it should include at least three tests on the particle size distribution of nebulized drugs. The FDA approved atomization particle test is a multi-stage impact test method, which is different from the laser scattering method commonly used in our domestic testing. At present, there are few laboratories in China with testing equipment, methods, and experience in FDA approval, so the choice of laboratory is very important.5. Lifespan characteristicsThe impact of the lifespan of atomizers on atomized particles and their impact on cleaning and disinfection is also a concern for the FDA. In the past, it was easy for everyone to prove the product's compliance through verification after making a prototype. However, this approach often only proves that the product meets the corresponding validation requirements, but cannot prove that the product meets the corresponding validation requirements throughout its entire lifecycle. Finally, to summarize, for some medical devices that receive high attention from the FDA, the FDA has very high requirements for testing reports. Choosing a laboratory with successful experience and rich technical experience will be very important. With the increasingly strict FDA review, the review has now shifted from product descriptive information and accuracy to verification and confirmation reports. So the era of having no problems as long as a laboratory report is obtained, as developed in domestic registration and CE registration, is over.Similarly, choosing a consulting firm with experience in the same product is also a very important factor for the success of the project. Rui Enni Consulting has completed dozens of domestic, CE, and FDA projects for disposable atomizers, compression atomizers, ultrasonic atomizers, and mesh atomizers. I have accumulated rich practical experience in the characteristics of atomizers, and some consultants have also worked in companies in the atomizer industry. These experiences will help Ryan Ni better provide consulting services for atomizer companies.