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     · How can ISO 13485 certification in South Africa help with MDR compliance? Aruna certvalue. 03 Feb 2021 • 83 Views. As a medical device manufacturer, if you are implementing an ISO 13485 2016 certification in South Africa Quality Management System (QMS)

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  • ISO 13485 Certification in South Africa

     · ISO 13485 certification in South Africa is the most widely used standard bye medical devices manufacturing organization because ISO 13485 stands for medical devices quality management system, or can also be addressed as a quality management system of medical devices.

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    As a medical device manufacturer, if you are implementing an ISO 13485 2016 certification in South Africa Quality Management System (QMS), you may wonder how the new European Union Medical Device Regulations (EU MDR) affect you, and how your Quality Management System can help with meeting these new requirements. This article will assist to give an explanation for the relationship

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  • ISO 13485 2016Medical Devices Quality Management

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  • Quality Management System (QMS) ISO 13485 Certification

    ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system.

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  • ISO 13485 Foundation Course South Africa ISO 13485

    Our ISO 13485 Foundation Course Training in South Africa will help you to understand the fundamental concepts of Medical Devices Quality Management System (MDQMS) as indicated in ISO 13485. Training provided by accredited Trainers. Online and Classroom training available.

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    Candidates will be able to audit their quality management system for conformity to ISO 13485, the effectiveness of their business processes, and to identify opportunities for improvement. South Africa

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  • ISO 13485 certification in South Sfrica, ISO 13485

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  • ISO 13485 2005 Certification for Medical Devices

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