This training covers the regulatory framework governing CE marking of medical devices and clinical investigations in the EU.
Changes coming to regulations and guidance on Medical Devices Clinical Investigations
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 can also cover the FDA Regulations governing medical devices in the US.
We then turn to Clinical Investigations with Medical Devices and their role in demonstrating Conformance for CE marking.
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.
Please contact me for more information and to organise your course.