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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

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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.

 

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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