Because the medical industry has the characteristics of high risk and high accuracy, its medical device standard is different from the general device standard. In terms of the strictness of the standard, the inspection standard of medical devices is the strictest. The following describes the main standards and characteristics of the medical device industry. This standard is applicable to the design, development, production, installation and service of medical devices or the design, development and provision of related services.
1. The standard is an independent standard with strong professionalism, which is only applicable to the medical device industry. The standard emphasizes the requirements of laws and regulations, and many places do not overemphasize the requirements of customers. This is because customer satisfaction is not suitable for the regulatory objectives of medical devices, which is consistent with the coordination objectives of management system regulations all over the world.
2. The standard emphasizes the special requirements for medical devices. Combined with the characteristics of the medical device industry, the standard adds many professional regulations. Such as special requirements for active implantable medical devices and implantable medical devices. 3. ISO13485 standard is a supplement to the technical requirements of products. All requirements of this standard are for the organization providing medical devices, regardless of the type or scale of the organization. If the regulatory requirements allow the deletion of design and development control, it can be considered reasonable to delete them in the quality management system. These regulations can provide another arrangement, which should be explained in the quality management system. It is the responsibility of the organization to ensure that deletions from design and development controls are reflected in the declaration of compliance with this standard.
Medical harness

The medical device defined in the standard refers to the instrument, equipment, appliance, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related articles that the manufacturer's intended use is for human beings for one or more of the following specific purposes, whether used alone or in combination. Experts from Shanghai Yuansu Electronic Science and Technology Bureau Co., Ltd., which has been engaged in medical harness processing for many years, said that in China, if the harness processing manufacturer can obtain ISO13485:2003 standard certification, it can basically meet the needs of medical harness.