As a long-term cooperative old customer of our company, Xingzhou Electronics signed a series of CE cooperation contracts in early June 2017, including:1) The first CE certification of 8 electronic thermometers;2) CE rectification of infrared thermometer;3) CE rectification of compression atomizer;4) CE rectification of ultrasonic atomizer. Under the good preparation and planning of both parties, and with the expertise of our company, we completed the writing and submission of CE technical documents within 2 months, obtained CE audit approval in October, and obtained CE certificate in early November. This is just the beginning of another milestone cooperation, and in the future development, we will support each other and help our clients grow and expand.

Huizhou Jinhao Electronics is a company specializing in the development and production of medical devices such as nebulizers, hearing aids, and alternating pneumatic mattresses.The company originally cooperated with a domestic consulting company, but the CE connection rectification of the hearing aid failed to pass the audit three times.After being recommended by SGS, we will cooperate with our company.The case was personally handled by our company's general consultant, who made improvements to multiple aspects such as the clinical evaluation report, instructions, and PMCF discovered during the audit.Especially for the drug compatibility assessment required by SGS UK, a systematic verification and evaluation were conducted from multiple perspectives.After rectification, passed the technical review of SGS and obtained the CE certificate.And immediately confirmed the project cooperation for CE registration and ISO 13485-2016 version upgrade certification of subsequent new products in the later stage.We follow the principle of being a customer and making friends; Our business philosophy is to create a case and establish a long-term client, and we will continue to focus on providing more services to our clients with professional skills!  

Dongguan WELLPOWER Sports Equipment Co., Ltd. is a well-known Taiwanese enterprise with factories in Liaobu, Dongguan and Ganzhou, Jiangxi, employing over 5000 people.The company mainly produces various sports equipment on behalf of international top sports brands such as Nike, Adidas, and Cardinon. In order to expand the company's new profit pivot, the company has launched the design and production of medical corrective equipment, elastic socks and other medical devices.To ensure compliance with the requirements of QSR 820 in the United States and obtain orders from American pharmaceutical chain giants. The company proactively applied for a third-party audit in accordance with the requirements of US GMP.Under effective organization, implementation, and guidance in the early stage, a three-day GMP audit was passed.The audit process follows the requirements of QSIT in the United States, including design and development, management responsibilities, production processes CAPA、 Detailed audits were conducted on the instrument and equipment, document management, and procurement management modules. After the audit, the result was very satisfactory and appreciated by the auditor.

Shenzhen Rongfeng Technology Co., Ltd. was originally a trading company, but due to the company's business development needs, it began to establish a factory.The company mainly produces Class II active medical devices, such as electronic thermometers, infrared thermometers, blood pressure monitors, and other products.With the efforts of the factory and consulting company, we successfully passed the system assessment of two auditors on July 29th.During the audit, the auditor conducted audits on the company's on-site, inspection and testing, authenticity verification of registered prototypes, design and development, supplier management, training and assessment, and other modules.Special emphasis was placed on the verification of the authenticity of the registered prototype and the detailed review of the design and development modules.

Huizhou Jinhao Electronics is a company specializing in the development and production of medical devices such as nebulizers, hearing aids, and alternating pneumatic mattresses.The company originally cooperated with a domestic consulting company, but the CE connection rectification of the hearing aid failed to pass the audit three times.After being recommended by SGS, we will cooperate with our company.The case was personally handled by our company's general consultant, who made improvements to multiple aspects such as the clinical evaluation report, instructions, and PMCF discovered during the audit.After rectification, passed the technical review of SGS and obtained the CE certificate.Through this initial cooperation, the customer market, research and development, and quality departments have highly recognized our company's capabilities.And immediately confirmed the project cooperation for CE registration and ISO 13485-2016 version certification of subsequent new products.We follow the principle of being a customer and making friends; Our business philosophy is to create a case and establish a long-term client, and we will continue to focus on providing more services to our clients with professional skills!

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.