Service content-Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.

QSR 820 in the United States requires the development of systematic and standardized procedures in institutions, personnel, factories, facilities and equipment, hygiene, verification, documentation, production management, quality management, product sales and recycling, complaint and adverse reaction reporting, self inspection, and other aspects. By implementing these procedures, a common goal can be achieved

查看详情 +

ISO 13485

2024-06-03

ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes is the current version up to November 2017.
----The following is an introduction to the old version, which has been invalidated. Some content can still be referenced.

查看详情 +

FDA certification in the United States

2024-06-03

The US Food and Drug Administration (FDA) is a subsidiary of the US Department of Health, Education, and Welfare, responsible for the management of drugs, food, biological products, cosmetics, veterinary drugs, medical devices, and diagnostic supplies nationwide.

查看详情 +

EU CE certification

2024-06-03

In the EU market, the "CE" mark is a mandatory certification mark. Whether it is a product produced by internal enterprises in the EU or products produced in other countries, in order to circulate freely in the EU market, it is necessary to attach the "CE" mark to indicate that the product meets the basic requirements of the EU's "New Methods for Technical Coordination and Standardization" directive. This is a mandatory requirement of EU law for products.

查看详情 +

Medical device registration

2024-06-03

Medical device registration is a process in which the food and drug regulatory authorities, based on the application of the applicant for medical device registration, systematically evaluate the safety and effectiveness research and results of the medical device intended for sale in accordance with legal procedures, in order to decide whether to approve their application.

查看详情 +