In this presentation, Dr. Colquhoun explains the circumstances in which medical device manufacturers need to generate de novo clinical data. The audio conference also looks at the different types of clinical evaluations and the importance of conducting them in the EU (and USA).
The speaker presents an overview of the regulatory and quality controls of evaluations being conducted in the EU, and then highlights specific requirements in the four most popular European countries for medical device evaluations. These requirements are then compared and contrasted to those of the USA. Finally, the presentation addresses general topics such as vigilance requirements, language and the operational process of conducting trials in the EU and USA.
This event is presented by Dr. Helen Colquohoun of Pleiad Devices. To learn more, please visit www.fxconferences.com.
