ISO 13485 and Beyond

Medical products are vital to life-saving, AMT maintains a rigorous attitude toward their design and production. The touch panel we produce is only a component of medical equipment. Our clients need to assemble the machine before it can be certified and sold in the market. However, medical regulations vary in different countries and areas, for example, in the United States, medical equipment needs to be approved by the FDA before launching, and in some countries, some equipment may not be regarded as medical devices while others consider they are and need to conform to medical regulations. We investigate the future market of our clients and customize our products so they comply with the local medical regulation.

All factories that produce medical equipment, devices, or systems need to have ISO 13485 certification. This specification can ensure that medical-related products meet medical regulations during the development and production process to achieve the best product quality and operating efficiency. A manufacturer must have its supply chain safety and risk management fully accessed to obtain ISO 13485 certification. AMT's products comply with the requirements of ISO 13485: We introduce product life cycle management, thoroughly review potential risks of the operation process, strengthen process control, draft rigorous process specifications, and design with future medical product certification in advance.

A comprehensive package for our clients

In addition to ISO 13485, AMT also complies with ISO 9001, ISO 14001 and ISO 45001 standards to provide the best touch product quality, friendly environment, and employee safety certification. With the global epidemic spreading, AMT will launch more new products in the hope that our high-quality medical components can contribute to the health of our partners, customers and all mankind!