March 22, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (hereinafter referred to as "Mindray") and the world's leading third-party quality and safety services Intertek, a satellite program awarding ceremony was held in Shenzhen, Intertek formally announced that Mindray The “Satellite Program†level 3 laboratory accreditation. Mindray Medical is the first company in the Greater China medical industry to receive Intertek's "Satellite Plan - Level 3", which includes anesthesia machines, ventilators, ultrasound systems, monitors, biochemical analyzers and blood cell monitors. Collaboration in the field of medical device testing and certification is further deepened.
Intertek's "Satellite Plan" Awarding Ceremony
"Satellite Plan" is a revolutionary service model developed by Intertek based on market demand. Based on the internal laboratory test data of high-quality manufacturers, it can issue relevant test reports, which can help manufacturers better. Control the process of product testing and certification, and speed up the certification. The "Satellite Program" will be able to issue a flag authorization report within 5 days at the earliest, to win more extra sales time for customers and get valuable time to market.
Acquired the “Satellite Program†Level 3 Laboratory Accreditation Representative Mindray's professional testing team is able to conduct product structure inspections and provide reliable data on its own, and Intertek will issue a report. Prior to this, Intertek gave the company's professional testing staff system training including quality system, certification technology and certification standards, and report writing process. As early as 2007, Mindray's Reliability Testing Laboratory became the first self-built laboratory in the industry to be accredited by the China National Accreditation Service for Conformity Assessment (CNAS). The laboratory testing capabilities include 70 domestic and international standards including IEC60601 series and IEC61010 series, covering the scope of monitors, defibrillators, anesthesia machines, ventilators, ultrasound systems, biochemical analyzers, blood cells, DR and MRI. Large product line, as well as EMC full test. The successful acquisition of the qualifications of the 3rd-level laboratory of the satellite program also represents the recognition of the international quality and safety institutions for the hardware facilities, management level and technical capabilities of the Mindray laboratory. Ms. Guo Yanmei, Senior Vice President of Mindray, said: “As a large-scale manufacturer specializing in the medical field, Mindray is committed to providing high-tech medical equipment with leading technology and high quality to the global medical industry. Through cooperation with Intertek, we are able to This market-oriented and flexible and professional service model better integrates R&D and testing and certification processes to improve the overall efficiency of the entire quality management system."
In recent years, China's medical equipment exports have grown steadily. After small and medium-sized medical equipment and equipment such as B-ultrasounds, monitors, anesthesia machines, etc., which mainly cover foreign markets such as Europe, America and emerging economies, large-scale diagnostic and therapeutic equipment such as MRI equipment. Become the main development direction. A group of companies with independent research and development capabilities and technological innovation capabilities represented by Mindray are mainly focusing on mid-end and high-end products, and gradually expanding their market share and influence in the international medical industry chain. Mr. Pan Jiarui, President of Intertek Asia Pacific, Commercial and Electronic, said: “Intertek has many years of service experience and expertise in medical testing and certification. We cover test certification, market access, third party audit, evaluation, system and consulting. The one-stop solution also provides customers with the greatest convenience. We are willing to use high-end products such as MRI, X-Ray, CT, centrifugal separators, etc. in well-known enterprises in Europe, America, Japan and South Korea. The service experience provides a useful reference for Chinese medical equipment manufacturers to help companies enhance their product technology and core competitiveness."
At present, the current self-completed test projects of Mindray's accredited laboratories include ETL certifications recognized by North American retailers and purchasers and globally accepted IEC standard tests. Pan Jiarui said that with the further development of the cooperation between the two parties, Mindray will It is possible to apply for the satellite program level 4, the highest level laboratory, for greater convenience.
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