Main contents of the announcement : Fenda Technology received the ISO13485: 2003 Quality Management System Certificate (certificate registration number: 49401) issued by National Quality Assurance (NQA). The certificate is valid for three years. The acquisition of the quality management system certification marks that the design and production of the company's mobile medical products meet the requirements of the ISO13485:2003 quality management system. Mobile medical technology has made substantial progress, and the product's subsequent volume can be expected. NQA is one of the largest and most prestigious ISO standard certification bodies in the world. The ISO13485:2003 standard is a certification standard for the medical device industry . In combination with Fenda's layout in the field of intelligent hardware, we believe that Fenda is actively promoting the development and production of medical-grade wearable products. Judging from the company's existing technical strength and product development experience, mobile medical products are expected to be put on the market in 2015, and the subsequent heavy volume can be expected. Actively transform the overall solution provider of intelligent hardware, and endogenous and external expansion. The company is rapidly advancing into the field of intelligent hardware, and is aimed at enterprise customers. It is committed to becoming a smart hardware overall solution provider of “hardware + software + cloud service†and has become a smart wear product supplier for large customers such as Huawei and Lenovo. Fenda's independent research and development record is remarkable: in June 2013, smart watches were launched; in June 2014, smart bracelets were launched; in September, Huawei's hand-playing bracelets were mass-produced; in October, it became qualified for Lenovo Group's smart wearable products. supplier. At the same time, the outreach mergers and acquisitions frequently shot, has laid out three key components of intelligent hardware: Guangju Communication, specializing in the application of MEMS sensors and sensor signal integrated chips (FPGA) for digital blood pressure, flat panel health monitors and other products and Module design and supply, focusing on health monitoring equipment; Otto Technology, investing in smart wearable terminal products, launched the smart glasses CoolGlass ONE (cool mirror) at the CES Electronics Show in January 2015; Ai Pico, sensor solutions Business, the main product categories include ambient light sensors, distance sensors and infrared sensors. Profitability is supported. The company's hairdressing small appliances and electro-acoustic business, long-term cooperation with international high-end customers, sustained steady growth and good cash flow provide a solid foundation for the company's rapid transformation to intelligent hardware. The recent acquisition of Oupanda's performance is in an outbreak, synergy is highlighted, high-performance commitments and low-value acquisitions have significantly improved the company's profitability. The performance burst is expected to be superimposed on the valuation premium, and it is recommended to actively increase the holdings on dips. Assume that Oupanda is consolidated in 2015, and the EPS of 2014-2016 is expected to be 0.47/1.17/1.56 yuan respectively. The performance is highly flexible. The mobile medical certification has successfully passed the high expectations of the development of intelligent hardware, giving a valuation of 45-50XPE in 2015. The price range of 52.65-58.50 yuan, the recent stock price rise reflects the company's development logic has initially gained market recognition, it is recommended to actively bargain. Risk Warning: There is a big uncertainty in the progress of the popularity of smart wearable devices. Introduction to ISO13485:2003 ISO13485: 2003 standard English name: Medical device-Quality management system-requirements for regulatory, Chinese translation: Medical device quality management system for regulatory requirements. The standard is based on medical device regulations, emphasizing the importance of implementing medical device regulations, proposing relevant medical device regulatory requirements, and ensuring the safety and effectiveness of medical devices by meeting this requirement. The State Food and Drug Administration changed it to the industry standard YY/T0287:2003 according to the principle of equivalence. Compared with the ISO9001: 2000 standard as the quality system requirements for general-purpose products, although the two chapters have the same structure, the ISO13485 standard is an independent standard specifically for the medical device industry. It is not an implementation guide for the ISO9001 standard in the medical device industry. It does not exist. Affiliation, not compatible. Wenzhou Celecare Medical Instruments Co.,Ltd , https://www.celecaremed.com
Fenda Technology Announcement: Mobile Medical has made substantial progress
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