Case Company Introduction: XX Technology (L~~~~) is a digital 3D intelligent manufacturer specializing in the research and development of 3D printing equipment, software, and materials, committed to changing the way products are developed and produced. The team has developed high-performance material systems suitable for different industries, relying on independently developed XX series printers and supporting software to provide solutions for innovation and upgrading in industries such as footwear, dentistry, healthcare, consumer, and automotive. They aim to create a new digital manufacturing model and ecological loop that combines customization and mass production.Rui Enni provided MDSAP certification coaching services for the company established in Silicon Valley, USA (USA+Canada+Australia+Japan). We provided remote tutoring for 3 months and successfully obtained the MDSAP certification.

Shenzhen Science and Technology Industrial Co., Ltd. was established in 1991. It is a national high-tech enterprise that integrates professional independent design, research and development, production, and sales of various measuring instruments and meters. It is the president unit of the Shenzhen Instrumentation and Automation Industry Association, the vice president unit of the China Indoor Environment Purification Industry Alliance, the vice president unit of the Guangdong Indoor Environmental Health Industry Association, a participating unit in the "Classification of Indoor Air Quality for Infants and Young Children" standard and the "Classification of Particle Purification Performance of Filter Air Purifiers" standard, and the drafting unit of the "Infrared Human Surface Temperature Rapid Screening Instrument" national standard.The enterprise always adheres to quality first, continuously improves its management system, and gradually establishes a sound product quality management system. Since 2004, it has passed ISO9001 quality certification and ISO13485 medical quality system certification, meeting customers' requirements for product quality. The company has won honors such as "National High tech Enterprise", "Top 100 Taxpaying Enterprises", "Shenzhen Famous Brand" and "Leading Enterprise" in its development process.Rui Enni's assistance to the company in obtaining the "Dual level Non invasive Ventilator" lasted for 10 months. We also wish the company smooth sailing and Yang Fan moving forward!

Xiamen Intelligent Technology Co., Ltd. utilizes its unique advantages to focus on providing customers with comprehensive services in rehabilitation therapy, healthcare equipment, and smart consumer electronics products. Our team has extensive experience in the fields of rehabilitation and intelligent devices, with strong research and development capabilities. We innovate based on the standards of "high standards, high quality, high efficiency, high safety, and high performance", and strive to explore the development direction of leisure life. We are determined to create a cross industry ecosystem in the field of leisure life and provide a comprehensive solution for "maintaining life baselines and optimizing life character" for the global leisure life community.The company's main products include air pressure therapy equipment series, medical transfer bed series, nursing mattresses, and DVT (deep vein thrombosis therapy equipment) series. The product quality is excellent, the price is reasonable, the design is novel, the materials are environmentally friendly, and the service is sincere, winning the trust of domestic and foreign customers.Our product has become one of the professional brands with influence and competitiveness in the same industry.Rui Enni helped the company's pneumatic therapy device obtain the domestic Class II medical device registration certificate, which took a total of 9 months.

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!!