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European Medical Device Regulations

Picto Training European Medical Device RegulationsRequirements 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

Training Application Form

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CE Marking Guide

LNE G MED CE Marking of Medical Devices Help you navigate through the complex regulations of medical devices in Europe.

 

IVD Guide

LNE G MED CE Marking IVD Medical DevicesUnderstand the IVD (in vitro diagnostic devices) role in the diagnosis and treatment of diseases around the world, including Europe.

 

MDSAP Prepare the transition, worldwide market access

combo ISO 13485 9001

Questions?

We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States

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Due to rapid growth in North America, we're seeking Lead Auditors and Certification Project Managers responsible for medical device manufacturing clients.

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