Menu Close

In-house Courses

Supporting individual development in health research management


Course Title: Medical Devices & Clinical Development

Duration: 1 day

Course Description:

** THIS COURSE IS NOW FULLY BOOKED, PLEASE EMAIL INFO@RDFORUM.ORG.UK TO BE ADDED TO THE WAITING LIST**

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

Contact Us In-house course
First
Last

Open Virtual Courses
Learning & Development

Open Virtual Courses

Find out about the latest training courses from the NHS R&D Forum
Influence & Representation
Groups & Current Work

Influence & Representation

R&D Forum contributes to NIHR Framework for Restart
R&D Contacts Directory
Resources & Output

R&D Contacts Directory

The contact details of all R&D offices across the UK.