ISO 13485:2016 Medical Device - Quality Management Systems Requirement and Interpretation

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*** SGS also provide e-certificate and e-document (e-document will be provided for In-house training only). This enables leaners to be free from certificate loss, to reduce storage space, and ultimately to be environmental-friendly to which SGS’s current policy is attached.***

This training provides you with an overview of requirements and interpretation of ISO 13485:2016, for medical devices quality management systems.

During this training, we will provide you to overview of the purpose and requirements & interpretation of ISO 13485:2016. Our trainers will help you to understand the intent medical devices management system standards and to learn how to successfully apply the principles of quality management to your organization.


• To understand of all requirements contained in ISO 13485:2016.
• To be able to plan, prepare and ensure in Quality management System focus on Medical Devices.
• To be able to maintain and control the Quality Policy, System, related to International Requirement and regulation for managing in risk management.




Recommended for anyone who involved in medical device manufacturing

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2 Days

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