CE Marking

CE Marking for Medical Devices

The CE Marking for Medical Devices Course is designed to provide you with an introduction to CE Marking requirements. Discussed are the directives for medical devices, electromagnetic compatibility (EMC), and low voltage. This course will supply you with an understanding of the directives for the medical device industry and how to prepare your company for compliance,

Who should attend?

This course is designed for presidents, business owners, managers, and anyone responsible for the implementation of CE Marking requirements.

Key Topics

Introduction to the European Union Directives
Introduction to CE Marking
Defining Directive Terminology
Transition Period
The Function of Notified Bodies
Technical Files
Understanding the Modular Approach to Conformity Assessment
Overview of Medical, EMC, and Low Voltage Directives
EN46000 requirements & EN724 Guidance on the application of EN46001

Course Duration

This is a one-day course and can be held at your site or at a venue close to your site. Please call us for a no-obligation, no-cost quote at 877-415-0191.

Thank you for your interest in BQPM Training!

Return to previous page