In-house Courses

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This course covers the regulatory framework governing clinical investigations in the EU and the UK.

First of all we consider the Regulatory Environment for medical devices including the currently applicable Medical Device Directives and the changes coming in with the new Medical Devices Regulations which will apply in the next few years.

We then turn to Clinical Investigations with Medical Devices and their role in demonstrating Conformance for CE marking and the requirements for the UK process post Brexit.

The main focus of the course is ISO14155, which provides guidance on Ethical Considerations, Planning and Management of Clinical Investigations and Roles and Responsibilities. There is also an overview of the changes anticipated with the forthcoming new version of ISO14155.

Course trainer

Jo holds a Certificate in Training and Development from the Chartered Institute of Personnel and Development, and was a Module Leader on the Clinical Research MSc programme run at Liverpool John Moore’s University. She is the author of a book on Continuing Professional Development and she regularly chair and speak at international clinical research conferences.

This webinar is suitable for those who need an introduction to the ethical and quality framework for clinical investigations of medical devices. This might include Project Managers, monitors, investigators, Sponsor representatives.

To provide delegates with an understanding of:

• The regulatory framework governing clinical investigations
• Overview of ISO14155.
• Changes coming to regulations and guidance on Medical Devices Clinical Investigations