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MD-QMS Comprehensive EU Medical Device Regulation 2017/745 (EU MDR) Practitioner (Medical Device – Quality Management System)

This course aims to provide learners who have an existing, basic knowledge of, or experience in, quality management in the Medical Device Industry with an in-depth understanding of the application under the European Union’s Medical Device Regulation (EU-MDR 2017/745) Regulation.

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MD-QMS ISO 13485:2016 Foundation (Medical Device – Quality Management System)

This course provides learners who have an existing, basic knowledge of, or experience in, quality management in the Medical Device Industry and in the context of the requirements of ISO 13485.

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MD-QMS ISO 13485:2016 Internal Auditor (Medical Device – Quality Management System)

This course provides learners with the knowledge and skills to perform an internal audit of part of a quality management system based on ISO 13485. and applicable international regulatory standards report on the effective implementation and maintenance of the management system.

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MD-SAP Auditing Approach (Medical Device – Single Audit Program)

This course aims to provide learners with the knowledge and skills required to understand and complete an audit against the IMDRF Medical Device Single Audit Program (MDSAP AU P0002.005) for medical device quality management.

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MD-QMS ISO 13485:2016 Auditor Conversion (Medical Device – Quality Management System)

The course is aimed at learners wishing to expand their existing management system knowledge and audit skills to include ISO 13485 and applicable international regulatory standards audits in accordance with ISO 19011, ISO/IEC 17021 requirements as applicable.

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MD-QMS EU MDR 2017/745 Auditor (Medical Device – Quality Management System)

This course aims to provide learners with the knowledge and skills required to perform audits of medical device quality management systems (MD-QMS) against the European Union’s Medical Device Regulation (EU 2017/745) in accordance with ISO 19011 and ISO 17021 as applicable.

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MD-QMS ISO 13485:2016 Lead Auditor (Medical Device – Quality Management System)

This course aims to provide learners with the knowledge and skills required to perform first, second and third-party audits of medical device quality management systems against ISO 13485 and applicable international regulatory standards in accordance with ISO 19011, ISO/IEC 17021.

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