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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

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.

 

Questions?

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

   1-301-495-0477

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clientsWe're Hiring!

Due to our rapid growth in North America, we're seeking Lead Auditors, Certification Project Manager Active and Certification Project Manager - In Vitro Diagnostics responsible for medical device manufacturing clients.