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ASUS VivoWatch obtains TFDA, ISO 13485 certifications

Edited and reported by Digitimes

Medical care devices are closely relevant to human health. Therefore, all countries have very stringent standards when it comes to medical devices. ASUS VivoWatch boasts "electrocardiogram application software" and "blood pressure application software," both of which have obtained certification from the Taiwan Food and Drug Administration (TFDA). The application software is the first proprietary healthcare wearable electrocardiogram and blood pressure application software researched and developed in Taiwan. Currently, the company is in the process of applying for FDA certification in the United States, and several medical institutions are working with ASUS to create various value-added services through VivoWatch. ASUS Chief Operating Officer and Global Senior Vice President, Joe Hsieh, pointed out that the interest proves the functions and qualities of the watch have gained trust in the market.

In recent years, health awareness has been soaring. Tracking physiological data through wearable devices and extending various smart value-added services have become an important trend in the next-generation healthcare industry. However, Hsieh said that it is not easy for wearable devices to enter the smart medical systems. ASUS has long been focused on mobile health (mHealth), aiming to create more applications in healthcare systems via continuous physiological monitoring features. Therefore, the company conformed to a high standard to satisfy the needs of both consumers and medical institutions during the design and development stages of VivoWatch. This is the main reason ASUS works well with multiple major domestic hospitals.

To better address medical needs, the software and hardware efficacies of VivoWatch are strengthened simultaneously. For the hardware aspect, ASUS is a major manufacturer in the information and communications industry, and its technology capacities have long been recognized by the market. The advantage has been further extended to produce VivoWatch's functions. For example, VivoWatch is equipped with two key sensors — electricalgraphy (ECG) and photoplethysmography (PPG) sensors. Moreover, the entire product series is independently researched and developed by ASUS, including the underlying architectures, software, hardware, and product features. Therefore, ASUS is able to provide customized solution plans based on medical institutions' needs.

Hsieh also expressed ASUS's passion for the medical equipment field and its long-term commitment. For the past decade, ASUS has focused most of its efforts on algorithm development, technology research and development, and obtaining medical standard certifications. For instance, unfazed by the fuzziness of these processes, ASUS decided to have its parent company apply for ISO 13485 Medical Devices Quality Management Systems, allowing the designs, production, and management of all medical products of the parent company to obtain certification, instead of applying for certification through individual brands or subsidiaries at a smaller scale with limited influence. Thus, the undertaking demonstrates how much ASUS values its commitment.

Furthermore, to make the watch aligned with the company's values, ASUS decided to proprietarily conduct research and development, from the algorithm of operating systems to hardware architecture. The autonomy in technology development enabled VivoWatch to meet the needs of medical institutions. Therefore, in 2021 and 2022, VivoWatch won the National Innovation Award, Corporate Innovation Award, and Symbol of National Quality for the company, as its innovative features and qualities are well recognized by the market.

Hsieh pointed out that obtaining TFDA and ISO 13485 certifications, as well as winning both domestic and foreign awards, shows that ASUS made the right choice to expand markets and accumulate industry reputation in the long term. He reiterated that medical devices are closely related to the safety of the human body. Therefore, medical institutions require high-quality products and relevant services from their partners that can be trusted. ASUS has built strong technological capabilities in the information and communications industry. When facing complicated cross-border cooperation in technology and healthcare, ASUS respects the differences in corporate culture, division of authority and responsibility, laws and regulations, and business models. Thus, in terms of the development mindset or product features, the company can gain the trust of its partners from the healthcare field. In the future, ASUS will continue to uphold its original purpose, maintain its strategic direction, and become a reliable partner for the digital transformation in the healthcare industry.

COO and Global Senior Vice President of ASUS Min-Chieh (Joe), Hsieh

Credit:ASUS

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