Medical Device

In the intricate world of medical device manufacturing, adherence to international quality management standards is paramount. These standards not only ensure the safety and effectiveness of medical devices but also play a pivotal role in building trust among healthcare professionals and patients alike. Two prominent standards, ISO 13485 and ISO 9001, are frequently mentioned in this context. […]

Many people go to the hospital when their hearts feel bad, but the symptoms may disappear when they arrive and the ECG results are normal. This kind of disease is used to “hide and seek”. They are not easily detected during the usual physical examination. So this requires patient monitoring devices that can monitor and collect body

FDA, i.e. U.S. Food and Drug Administration, regulates the sale of medical device products in order to ensure the effectiveness and safety of such products sold in the United States. Companies that want to legally sell medical devices in the U.S. market need to obtain FDA approval first. So how do you obtain this approval?

In recent years, the healthcare industry has been gaining public attention. Especially during the COVID-19 pandemic, healthcare institutions and organizations around the world are working to find better ways to provide care. Among them, IoMT has made tremendous progress. In the predicted period, IoMT market will grow to over $397 billion by 2027. IoMT devices reduce

BACKGROUND In today’s society, digitalization has led to disruptive changes in many industries such as consumer goods, automotive, and banking. Today, digitalization is leading us into the era of “everything counts”, leading the trend of technological transformation and innovation in all industries. In the medical field, technological change and innovation is often slower than in the consumer

Since the discovery of X-rays, medical imaging technology has begun to change the way doctors diagnose and treat patients. Due to continuous technological advances, modern medical imaging devices are capable of performing highly accurate diagnoses. The two most important aspects of modern medicine are diagnosis and treatment. Diagnosis is the premise of medical treatment, and

Background After entering the 21st century, the level of science has significantly improved. And the progress of science and technology has also promoted the development of medical technology. The continuous development of medical electronic devices has provided protection for people’s health and promoted the harmonious progress of society. With the advancement of technology, portable medical

In recent years, with the development and progress of RF wireless technology, the application of RF wireless technology in various fields has become increasingly popular. Wireless medical device is one of the examples. However, withe the popularity of this technology, the wireless environment is becoming increasingly complex and crowded. For wireless medical devices, it is

The digital revolution has impacted the Internet of Things (IoT), the Internet of Medical Things (IoMT), and Software as Medical Devices (SaMD). In addition to this, it has even penetrated connected devices in hospitals and home healthcare environments. This revolution has also raised concerns about the phenomenon of medical device safety. Background According to incomplete

Background As the population ages, and with people’s increasing awareness of health care, the demand for home medical devices is growing. At the same time, with the rapid penetration and development of technologies such as the IoT, medical motives are also showing a trend of multi-level diversification. In recent years, the market demand for home medical devices