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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.

 

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 Non-Active Medical Device responsible for medical device manufacturing clients.

Training - 2 Days Course

Training EU Medical Device Regulations

 

European Medical Device Regulation 2017/745

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Combo Training ISO13485 MDSAP

Transition to ISO 13485:2016

& The fundamentals of the Medical Device Single Audit Program (MDSAP) for Medical Device Manufacturers

Click here to Register

Our Clients Say

"We traveled from Massachusetts to attend the 2days LNE/G-Med ISO 13485:2016 and ISO 9001:2015 transition training and it was well worth the trip. The training was interesting, informative and interactive. The case studies were a great way to try and apply the new aspects of the standards and brainstorm with others. The chance to meet and discuss the new standards with actual LNE auditors was a huge plus."
Dan Massucco - Vice President of Quality Assurance and Regulatory Affairs

"I just thought you might like to know that we completed our transition audit with only three minor NCs. The auditor was very impressed that we did this on our own without the benefit of a consultant. I give much of the credit to your training class and want you to know that I really think you did an excellent job with the training."
Sue Powell - Quality Manager