ISO 13485 quality management system certification of medical devices is an important basis for medical devices to meet the requirements of relevant laws and regulations of most countries, and also the embodiment of your commitment to meet customer requirements. However, in most countries, the compliance of medical device manufacturers with ISO 13485 standard is not enough to meet all regulatory requirements. For medical device subcontractors, component manufacturers, service providers and medical device distributors, they usually only need to obtain ISO 13485 certificates. Whether for brand holders, small manufacturers, or multinational enterprises, medical device certification is also applicable.

1. It is applicable to one or more stages of the life cycle of medical devices, including the design and development, production, storage and distribution, installation or maintenance of medical devices and the design and development or provision of related activities (such as technical support). It can also be used as a supplier or external party to provide products (including services related to quality management system) to such organizations.
2. The system operation shall not be less than 3 months;
3. Companies required to obtain ISO13485 certification and registration must have at least 3 consecutive months of management system records, including complete records of internal review and management review.

1. Contract
2. Application
3. Business license and organization code certificate (within the validity period)
4. Other valid qualification certificates (product production license, etc., when applicable)
5. Company profile
6. Organization chart
7. Product process flow chart
8. Product description (if applicable, such as: the final product needs to be provided);
9. List of applicable laws and regulations, including product standard list (if applicable, such as the final product to be provided);
10. Recent national and industrial product / service supervision and spot check report (if any);

1. Submit application
2, pre-trial
3. Formal review
4. Issue certificate
5. Supervision
6. Recertification

1. It helps to eliminate technical barriers in international trade and is the passport to enter the international market
2. Improve the management level of the organization
3. Improve business reputation
4. Improve the level of product quality assurance
5. Conducive to enhancing the competitiveness of enterprises
6. Improve the internal management of the organization

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