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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.

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.