Auditing courses

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Management systems (3)
Auditing (2)
Internal Auditing (1)
(-) Medical devices (3)

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CQI and IRCA Certified Training (3)

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Course code

PT219

Course code

Duration

24 hours

Category Auditing

Level Practitioner

Scheme(s)

Medical devices

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.

CQI and IRCA Certified Training
Assurance
Health and medical
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.