The aims and learning outcomes of this course are:

To understand the European Regulation for Medical Devices.
To appreciate the EU requirements for selling Medical Devices.

Following completion of this course, participants should:

Understand the European Medical Device Regulation.
Be able to actively participate in preparing documentation for technical files.
All participants should have a working knowledge of the requirements.

This five module course is held live in an online lecture theatre and delivered with a PowerPoint presentation. All participants will fully engage with the lecturer through both group and individual exercises and direct participation throughout the course. There are exercises included in order to ensure the course contents are fully understood and the opportunity is always available for participants to ask questions.

OC035 explores the European Medical Device Regulation and is broken down into 5 modules.