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  6. Medical Device Quality Management System ISO 13485

Medical Device Quality Management System ISO 13485

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last updated:Feb 28, 2023

ドイツ品質システム認証
ドイツ品質システム認証
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Advantage in new market entry and overseas exports due to international standards! Introduction of benefits of acquisition, etc.

ISO 13485 is the international standard for medical device quality management systems. Companies that belong to one or more stages of the entire lifecycle of medical devices, from design and manufacturing to disposal, are eligible for certification. DQS Japan provides audit and registration services from the customer's perspective, keeping in mind that "there are as many systems as there are organizations," allowing management to determine whether the management system is truly beneficial within the organization. 【Benefits of Acquisition (Excerpt)】 ■ Competitive advantage in new market entry and overseas exports due to international standards ■ Increased trust from the market and customers, improved customer satisfaction ■ Contribution to employee awareness improvement and corporate culture enhancement ■ Standardization and clarification of work, increased sense of achievement in operations ■ Compliance with laws and regulations, enabling more accurate risk analysis *For more details, please refer to the PDF materials or feel free to contact us.

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Medical Device Quality Management System ISO 13485

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Germany Quality System Certification Co., Ltd. Company Information

Germany Quality System Certification Co., Ltd. Company Information

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Medical Device Quality Management System ISO 13485

Medical Device Quality Management System ISO 13485

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ドイツ品質システム認証

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DQS Japan is a specialized organization with a headquarters in Germany and over 30 years of experience. As a partner to Japanese medical device manufacturers, we provide medical device certification services for both Japan and Europe. In Japan, we operate as a registered certification body, conducting certification for highly controlled medical devices and controlled medical devices. For Europe, we serve as the contact point for DQS Medizinprodukte (DQS Medical Devices), which is a Notified Body under the MDR.

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