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.

CQI and IRCA Certified Training
Assurance
Health and medical
Auditing
Management systems
Medical devices

Course code

FD132

Course code

Duration

8 hours

Category Auditing

Level Foundation

Scheme(s)

Medical devices

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.

CQI and IRCA Certified Training
Assurance
Health and medical
Auditing
Foundation Auditing
Management systems
Medical devices

Course code

PT264

Course code

Duration

Minimum of 14 hours

Category Auditing

Level Practitioner

Scheme(s)

Medical devices

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.

CQI and IRCA Certified Training
Assurance
Health and medical
Internal Auditing
Management systems
Medical devices

Course code

PT221

Course code

Duration

Minimum of 16 hours

Category Auditing

Level Practitioner

Scheme(s)

Medical devices

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.

CQI and IRCA Certified Training
Assurance
Health and medical
Auditing
Management systems
Medical devices

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.

CQI and IRCA Certified Training
Assurance
Health and medical
Auditing
Auditor/Lead Auditor
Management systems
Medical devices

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.

CQI and IRCA Certified Training
Assurance
Health and medical
Auditing
Auditor/Lead Auditor
Management systems
Medical devices

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.