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 based on ISO 13485:2016 and international regulatory bodies medical devi

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.

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.

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.

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, which is compatible with IMDRF members’ medical device regulators individual countr

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.