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In Vitro Diagnostic Medical Devices

Picto Training Course In Vitro DiagnosticBuilding the Technical File and Demonstrating Compliance

Course Objectives

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

  • Know the requirements for CE marking of in vitro diagnostic medical devices according to Directive 98/79/EC
  • Acquire a practical methodology for preparing the technical documentation according to Annex III.3, III.6, IV.4 and V.3
  • Identify data to include information on system quality, design manufacture, risk analysis, performance evaluation and stability studies

Training Application Form

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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.


combo ISO 13485 9001


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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clientsWe're Hiring!

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

ISO13485 Training

Transition to ISO 13485:2016
1 Day Course

Entrust a top training organization like LNE/G-MED to bring your employees up to speed!

The latest edition of ISO 13485 standard for the Medical Device Industry, ISO 13485:2016, was officially published February 25th, 2016. Medical Device manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance.

Training Content: Click here!

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Santa Clara, CA