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ISO13485 Medical Devices

Product introduction: ISO 13485, also known as 'Medical Device Quality Management System' in Chinese, is a special product for saving lives, helping injuries, and preventing and treating diseases. It is not enough to standardize medical devices solely according to the general requirements of the ISO9000 standard. Therefore, the ISO organization has issued the ISO 13485-1996 version standards (YY/T0287 and YY/T0288), which put forward special requirements for the quality management system of medical device manufacturers, and has played a good role in promoting the safety and effectiveness of medical device quality.ISO13485 is a quality management system based on the ISO9001 process method used in the medical device industry for regulatory requirements. It includes special requirements for the manufacturing, installation, service, and recall of medical devices to facilitate:-Improving the quality management system-Use risk management methods for control during the product implementation process-Process validation-Meet the requirements of laws and regulations-Effective control of product risks and recall managementThe Benefits of ISO13485 Certification-Helps to eliminate technical barriers in international trade and is a passport to enter the international market-Improve the management level of the organization-Enhance business reputation-Improve the level of ensuring product quality-Beneficial to enhancing the competitiveness of enterprises-Improve internal management of the organization
Project introduction: ISO13485 is a quality management system based on the ISO9001 process method used in the medical device industry for regulatory requirements. It includes special requirements for the manufacturing, installation, service, and recall of medical devices.
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ISO13485 Medical Devices
  • Project description
  • Customer case
  • Certification application

ISO 13485, also known as 'Medical Device Quality Management System' in Chinese, is a special product for saving lives, helping injuries, and preventing and treating diseases. It is not enough to standardize medical devices solely according to the general requirements of the ISO9000 standard. Therefore, the ISO organization has issued the ISO 13485-1996 version standards (YY/T0287 and YY/T0288), which put forward special requirements for the quality management system of medical device manufacturers, and has played a good role in promoting the safety and effectiveness of medical device quality.

ISO13485 is a quality management system based on the ISO9001 process method used in the medical device industry for regulatory requirements. It includes special requirements for the manufacturing, installation, service, and recall of medical devices to facilitate:

-Improving the quality management system

-Use risk management methods for control during the product implementation process

-Process validation

-Meet the requirements of laws and regulations

-Effective control of product risks and recall management

The Benefits of ISO13485 Certification

-Helps to eliminate technical barriers in international trade and is a passport to enter the international market

-Improve the management level of the organization

-Enhance business reputation

-Improve the level of ensuring product quality

-Beneficial to enhancing the competitiveness of enterprises

-Improve internal management of the organization


ISO13485 certification common issues

1. Q: The products produced by the enterprise do not belong to medical devices and their components. Can I apply for ISO13485 certification?

A: According to the ISO13485 standard, ISO13485 is applicable to one or more stages of the medical device lifecycle, including the design and development, production, storage and distribution, installation or maintenance, and related activities (such as technical support) of the medical device. It can also be used as a supplier or external party providing products (including services related to the quality management system) to such organizations.

2. Q: Where can a company check the validity of a certificate after obtaining it?

A: Unified query platform for certification and recognition business information: http://cx.cnca.cn/rjwcx/web/cert/index.do?progId=1212

List of Documents Required for ISO13485 Certification

1. Contract

2. Application Form

3. Business license and organizational code certificate (confirmed to be within the validity period)

4. Other valid qualification certificates (product production license, etc., if applicable)

5. Enterprise Introduction

6. Organizational Chart

7. Product Process Flow Diagram

8. Product manual (if applicable, such as the final product to be provided);

9. List of applicable laws and regulations, including a list of product standards (if applicable, such as the final product to be provided);

10. Recent national and industry product/service supervision and random inspection reports (if any).


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