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Due to the high risk and high precision of medical industry, the standard of medical equipment is different from the standard of general equipment. If only from the rigor of the standard, the inspection standard of medical devices is more strict. The following introduces the main standards and characteristics of the medical device industry. This standard is applicable to the design, development, production, installation and service of medical device wiring harness or the design, development and provision of related services and other related industries.

1. The standard is an independent and highly professional standard only applicable to the medical device industry. The standard emphasizes the requirements of regulations and does not overemphasize the requirements of customers in many places. This is because customer satisfaction is not compatible with the regulatory goals for medical devices, which are consistent with the goal of harmonizing regulatory systems worldwide.

2. The standard emphasizes the special requirements for medical devices, and adds many professional provisions in combination with the characteristics of the medical device industry. For example, special requirements for active implanted medical devices and implanted medical devices.

3. ISO13485 standard is a supplement to the technical requirements of the product, all requirements of this standard are for the organization that provides medical devices, regardless of the type or size of the organization. Where regulatory requirements permit the deletion of design and development controls, it may be considered reasonable to remove them from the quality management system. These regulations can provide alternative arrangements, which are explained in the quality management system. It is the organization's responsibility to ensure that deletions to design and development controls are reflected in statements of compliance with this standard.