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.The NMPA registration cooperation between the company's low-frequency therapeutic device and Ruini took 6 months from submission to approval to obtain the certificate.  

The client in Guangdong for this tutoring is located in Guangzhou. The client independently develops, produces, and sells thermometers, blood pressure monitors, ultrasonic nebulizers, IPL hair removal devices, oximeters, ventilators, etc. The customer's products are exported both domestically and internationally, and they have signed dozens of domestic, US, and EU registration and accuracy verification contracts with Ruini for their products; Obtained NMPA registration certificate after 8 months!

The customer is a well-known manufacturer of blood pressure monitors, and this MDSAP certification includes five member countries. The products include electronic blood pressure monitors (arm and wrist). Throughout the entire coaching process, our company dispatched two system consultants for comprehensive guidance. During the coaching process, they patiently provided guidance on QMS systematization, regulatory conversion, design and development modules, and ultimately successfully obtained the MDSAP certificate.

The customer is an electronic blood pressure monitor and infrared thermometer manufacturer headquartered in Dongguan and with a factory located in Jiangxi. The Korean client of the client requested KFDA certification. Upon receiving the commission, our company immediately planned a practical and detailed system coaching plan, and dispatched two system consultants for coaching. With mutual trust and active cooperation from both parties, we successfully obtained the KGMP audit from South Korea and obtained the certificate smoothly. The entire coaching cycle is 3.5 months.

The client is a high-tech enterprise in Shenzhen and a well-known brand in the medical beauty industry. The enterprise adopts a commissioned production model, and during the MDSAP certification coaching, the certificate holder and two commissioned production enterprises participated in the scope of this certification.The product range includes IPL hair removal devices and radiofrequency skin therapy devices. The entire tutoring period is 3.5 months, and during the synchronization process, the KGMP system was also tutored. Through our company's reasonable system coaching plan, three system consultants were dispatched to provide on-site coaching, successfully completing the preparation and review within the expected period of the client, and obtaining the certificate smoothly.

The customer is a French company that mainly produces electrical stimulators, including TENS and EMS technologies.The rectification audit cycle lasted for a total of 3 rounds. Throughout the entire certification audit and issuance process, our company collaborated with enterprises to complete communication and rectification of issues related to clinical evaluation, product technical characteristics, etc. by auditors one by one, and finally successfully obtained the MDR certificate.The entire cycle takes about 18 months.