证书号 60148244
证书号码: | 60148244 |
证书持有人: |
Cardiomatics Sp. z o.o. ul. Wojciecha Weissa 7/C1 31-339 Kraków 波兰 |
范围: |
Design and development, manufacture and servicing
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测试标准: |
EN ISO 13485:2016
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证书类型: |
QMS
Quality Management System The European standard EN ISO 13485 specifies requirements for a quality management system when an organization is required to demonstrate its ability to provide medical devices and related services that constantly meet customer requirements and applicable legal requirements. Competent auditors analyze and evaluate the customer's quality management system. If all applicable requirements are met, its quality management system is certified according to EN ISO 13485. The customer's quality management system is subject to regular monitoring. Certified customers may use the test mark in their communication. Further information on this service can be found here. |