European Medical Device Regulation

Requirements of Directives 93/42/EEC and 90/385/EEC

Course Objectives:

This program is designed to provide participants with a variety of knowledge and skills:

• Understand the European regulatory scheme for putting medical devices on the market (including the revision of regulations in 2007)
• Understand how the text of the Directives is held to know its key concepts
• Learn to determine the class of a medical device
• Understand what to implement in order to affix the CE marking on a device to be put on the European market

Learn More

To get a detailed curriculum, find out scheduled locations or request this program in your area, contact LNE/G-MED America.

For an economical way to train multiple staff, ask us about an on-site program at your company.