CE marking is a mandatory legal requirement for all medical devices placed on the market anywhere within the EU. This course provides those new to CE marking medical devices with an introduction to the requirements of the Medical Devices Directive, including the latest update 2007/47/EC which was mandatory from 21st March 2010.

High Edge Consulting are hosting a 2 day training course covering CE marking on September 5 – 6.  Directives often don’t make for easy reading and this course will enable you to understand the legalese and jargon to give a working understanding of the regulatory requirements.

The course will include all the major features of the Directive including, amongst others, product classification, conformity assessment routes and Technical Files including the Essential Requirements. The prime focus of this course will be on the Medical Device Directive, but will of course include reference to the IVD and AIMD directives.

The course aims to provide an an appreciation, knowledge and understanding of the main requirements of the directives, as well as an understanding of the regulatory bodies and additional requirements for your quality management system, including post production obligations.

For further informaiton, please click here.

To register for this event, please click here.