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    ISO 13485:2016 Medical Devices Management System Awareness

    ISO 13485 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.The requirements laid out in this standard system can also be used by suppliers or external parties that provides a product, including quality management system-related services to such organisations.

    ISO 13485:2016 Medical Devices System Lead Implementer

    This course introduces you to the concepts needed to understand, develop,and implement a Quality Management System (QMS). This course provides the knowledge and process steps to enable the effective implementation of a QMS that is in line with the requirements for ISO 13485:2016 certification.

    ISO 13485:2016 Medical Devices Management System Internal Audit

    ISO 13485 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.The requirements laid out in this standard system can also be used by suppliers or external parties that provides a product, including quality management system-related services to such organisations.

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