“No dates available for this course currently, but we hope to do so in the near future”

This course provides an introduction to the regulations and applicable Standards surrounding medical device clinical studies in the EU and UK.

We will review the impact of the Medical Device Regulation (2017/745) on the EU regulatory environment surrounding clinical investigations, and take a look at the evolving situation the UK.

We will then turn our attention to the clinical development stages, and by using the updated ISO14155:2020 (Clinical investigation of medical devices for human subjects – Good clinical practice) as a guide we will focus on some of the key changes while exploring site selection, the development of key study documentation and management, and potential audit requirements.

To provide delegates with an understanding of:

• The regulatory framework governing clinical investigations involving medical devices
• Understanding of the various clinical development stages
• Overview of ISO14155, including site selection, development of key study documentation and audit