Medical Devices Clinical Evaluation Implementation Training Course

Description

MD-CE

The aim of this course is to provide learners with knowledge and interpretive skills necessary to understand and implement the requirements of the new Medical Devices Regulations 2017/745 and Med Dev 2.7.1 Rev 4, Clinical Evaluation in relation to expectations for Clinical Evaluations.

Furthermore, learners will have a broader understanding of the changing landscape of regulations related to risk management with an objective of increasing patient safety.

Objectives

UPON COMPLETION OF THIS COURSE, LEARNERS WILL HAVE:

• Knowledge of when to perform clinical investigations;
• An understanding of who should perform clinical evaluations;
• Competence to perform clinical evaluations

Learners will need to demonstrate acceptable performance in these areas to complete the course successfully.

Audience

PRIOR KNOWLEDGE

Before starting this course, learners are expected to have the following prior knowledge:

• ISO 14155 Clinical Investigations of medical devices for human subjects – good clinical practise;
• ISO 14971 Medical Devices: Application of risk management to medical devices;
• Optional:

• MDR 2017/745 – basics.
• MED DEV 2.7.1 – basics.