Xingzhou ISO 13485:2016 Quality System Certification

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.