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European Medical Device Regulation 2017/745

2 days course, Register today!

 

We have now reached the first year anniversary of the new European Medical Device Regulation publication. Manufacturers are working on their Gap analyses and implementation strategy while Notified Bodies are going through the notification process. The transition period for the MDR is 3 years and 2020 is coming fast.

This course is designed for Medical Devices professionals working on the implementation of the European Medical Device Regulation 2017/745.

It will allow participants to be able to:

  • Understand the Structure and scope of the Regulation
  • Describe the regulatory requirements of Regulation 2017/745
  • Identify major changes between the Medical Device Directives 93/42/EEC and 90/385/EEC and the Regulation 2017/745

 

Training content and objectives
DAY 1 & 2: EU Medical Device Regulations
8:30 am to 9:00 am Breakfast
9:00 am – 12:15 pm

Program

  • Regulation structure
  • Scope and Definitions
  • Actors and Responsibilities
  • Device Classification
  • Assessment routes
  • Quality Management System requirements
  • Technical Documentation
  • Post Market Surveillance and Vigilance
  • Transition
12:15 pm - 1:00 pm Lunch
1:00 pm- 5:00 pm Program + Practice session
  • Workshop and Course Evaluation
  • Summary and Discussion

Register today!

LNE/G-MED NA retains the right to cancel the training 7 days before the date if the number of attendees is insufficient.

 

About the trainer
Florianne Torset Bonfillou LNE Gmed

Florianne Torset-Bonfillou
Director of Regulatory, Education and Quality – Lead Auditor
Florianne Torset-Bonfillou is the Director of Regulatory , Education and Quality at LNE/G-MED North America. She received her Bachelor’s Degree in Biology from the University of Burgundy and her Master’s Degree in Chemistry from University of Paris 12. She holds a professional certificate in Quality, Safety and Environmental Management. Prior to joining LNE/G-MED, Florianne worked in the Pharmaceutical and Medical Device industry as a Quality Assurance Project Manager.  At LNE/G-MED, Florianne is a Senior Design Dossier Reviewer and Lead auditor. She is also a trainer on the European Regulation, Quality Management, Risk Management, and other regulatory and quality topics.

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

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

Click here to Register


 

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