Medical Device Regulation (MDR) (EU) 2017/745 Internal Auditor Training Course
This course has been developed by SGS for the benefit of clients wishing to understand Medical Device Regulation (EU) 2017 – 745 and how to conduct an internal audit against its requirements.
Course Overview
What you'll learn
Upon completion of this course, learners will be able to:
- Plan, conduct, report and follow-up on an internal audit of their companies management system and technical documentation based on Medical Device Regulation (EU) 2017 / 745 requirements
Who This Course Is For
This course is designed for:
- Medical professionals involved in the internal audit of Medical Device Regulation(EU) 2017 / 745 requirements
Prior Knowledge
It will benefit learners if they have knowledge of the Medical Device Regulation (MDR) and an understanding of:
- The requirements of MDR
- Commonly used terms and definitions, as provided in the MDR
Virtual Course requirements:
To ensure your access to the virtual course and to gain the most out of this training we request all learners have:
- Reliable internet access (High speed)
- Computer with microphone and camera capabilities
Assessment and group activities for this course requires your camera to be turned on. Background effects such as blurring can be used for preserving privacy.
About this course
This course has been developed by SGS for the benefit of clients wishing to understand Medical Device Regulation (EU) 2017 – 745 and how to conduct an internal audit against its requirements.
The course refers to the Medical Device Regulation that provides the context for internal audit. However, this course does not address Medical Device Regulation in detail.
The course covers the following content:
- Overview of the Changes in MDR from MDD
- Auditing for Continual Improvement
- Audit Definition, Types and Principles
- Roles and Responsibilities of Auditors
- The Audit Process
- Preparing for the Internal Audit
- Conducting the Audit
- Audit Review
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