One day course that covers medical device regulations in Europe and the US.
Learn about the new medical device regulations in europe and their impact.
Course was developed by regulatory experts in the medical device sector.
This training is focused on the following key areas:
The attendee will gain an understanding of the following elements of the European medical device regulations:
The attendee will gain an understanding of the following elements of the US regulations applicable to medical devices
Manufacturing and Design Engineers involved in new product introduction and those that want to understand what is required when making changes to existing products and processes
Engineers will have the required knowledge in place to understand the basic regulatory requirements with respect to medical device. They will gain an appreciation of the routes to market for medical devices and understand what is required when changes are made post market. This knowledge will be invaluable in development of product strategies and when liaising with regulators and regulatory affairs.