Dongguan Xingzhou Electronics is a professional company that researches, produces, and sells household medical devices, including electronic thermometers, infrared thermometers, ultrasonic nebulizers, compression nebulizers, and more.Based on the previous cooperation foundation, the client has signed a long-term strategic consulting contract with our company, entrusting our company to provide guidance for the CE registration of the new product (electronic thermometer), maintenance of CE technical documents for the old product, and ISO 13485:2016 system certification.After the contract is signed, our company arranges professional system consultants to go to the client's site to provide customized training on ISO 13485:2016 system, process confirmation, risk management, and other related courses.After the training, the client was guided to improve and upgrade the existing system documents, and the complete set of system documents was promptly issued.At the same time, based on the customer's production process and product characteristics, we discussed and suggested suitable MDF, DHF, and batch record lists for the customer, and assisted the customer in establishing a complete system.During the preliminary review, our system consultant provided in-depth and effective suggestions for the customer's product inspection and testing, production process, and development design, which were unanimously recognized by the customer's company management.During the audit period, with good preparation in the early stage and the client's ability to master the system, we successfully passed the ISO 13485:2016 system audit and received a recommendation for certification on the spot.

Shenzhen Youren Technology mainly produces arm and wrist electronic blood pressure monitors and infrared thermometers. The company's two blood pressure monitor products have obtained 510 (K) and have been exported to the United States for more than a year.After receiving the FDA factory inspection notice, the client chose to cooperate with a well-known consulting company. After receiving routine training, the customer's company is still unable to proceed due to two months having passed due to basic and management adjustments, and the program files have not been confirmed yet. The company urgently needs to familiarize itself with factory operations and provide effective practical guidance for implementation.Time is extremely urgent, with only one month left. As the customer's FDA factory inspection preparation is about to fail, it has come to an end. After urgent internal discussions within the client's company and recommendations from an old client (Dongguan Aishi Electromechanical) who had undergone FDA factory inspections and guidance in the early stages, the client contacted us in the third month. Choose to collaborate with us.After signing the contract with the client, we arranged for the company's general consultant to provide on-site guidance. We have helped our clients develop a detailed FDA factory inspection preparation plan, and formed a working group based on QSIT inspection content and internal division of labor, clarifying their respective division of labor and timeline requirements. Then provide a large number of practical templates, from discussions on DMR, DHF, DHR lists and a complete set of forms, to personnel files, procurement files, process confirmation CAPA、 Discuss the production process and instrument and equipment management modules with management personnel one by one. Assist management personnel in opening up their thinking and guide them in carrying out their work.After more than a month of hard work by all the staff of the client, we have finally completed all the preparation work.During the review process, FDA auditors conducted a detailed examination of CAPA, data statistical analysis, clinical evaluation, 510K SE comparison, and management review.During the four-day audit, we worked together with the client on a daily basis, providing timely advice and effectively offering many forward-looking opinions to avoid the risk of non-compliance during the audit.  After four days of review, the client received high praise from the FDA auditor and achieved a good result of zero defects.In this audit, our general consultant provided on-site guidance to the client for more than 20 consecutive days, during which he often worked overtime to audit and guide the work at the client's site.After the review was completed, we received phone calls from three bosses of the clients thanking them and inviting them to travel with great hospitality.Through this collaboration, we have established a deep trust and camaraderie with our clients. It also strengthens our service philosophy: serving customers with care and establishing long-term and deep cooperative relationships!

Breast pump FDA 510K registered zero hair supplement, certified in 2 and a half months!