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Course code
PR370
Course code
Duration

Minimum of 24 hours

Category Auditing
Level Professional
Scheme(s)
Medical devices

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.

Course code
PR371
Course code
Duration

Minimum of 24 hours

Category Auditing
Level Professional
Scheme(s)
Medical devices

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.

Course code
PR371
Course code
Duration

Minimum of 40 hours

Category Auditing
Level Professional
Scheme(s)
Medical devices

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.