Course Title: Medical Devices & Clinical Development
Duration: 1 day
Course Description:
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.
Who is the Course for?
This webinar is suitable for those who are in need of an introduction or update to the ethical and quality framework for clinical investigations of medical devices. This might include project managers, monitors/CRAs, investigators, quality affairs or Sponsor representatives.
Learning Objectives:
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
All of the courses in our prospectus are available to run in your local organisation or region. A discounted price can be offered if a room can be provided free of charge or for guaranteed number of delegates. All courses require at least 15 delegates to run. We have various pricing structures for hosting an in house course.
If you would like to host a course then please contact the team for further discussion on info@rdforum.org.uk
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