BLOG: Clinical Testing 101
Clinical Testing 101 - January 21, 2015
Presenter: Alvira Macanovic, IP, Regulatory and Clinical Affairs Manager at CIMTEC
Description: A critical step in bringing a medical device to market is demonstrating the safety and effectiveness of the product. This webinar is meant to introduce participants to the role clinical trials play in the development of a medical device and to provide an overview of the process involved in carrying out a clinical trial within a framework of good clinical practices (GCP) and regulatory requirements. The focus will be on clinical trials for device approval in Canada, United States, and Europe.
The information presented in this presentation is intended to outline the general processes, principles and concepts of conducting clinical studies. Please note that these materials are provided for general information only and are not guaranteed to be correct, complete or up-to-date. They are not intended to provide detailed instructions for product development. Every medical imaging device is unique and therefore so are its associated regulatory needs. These materials should not be regarded or relied upon as regulatory advice, and specific advice should be sought from an appropriate professional.