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European Medical Device Regulation 2017/745

2 Day Training Course, May 6th-7th 2019

Fort Lauderdale, FL. 33301

For RA/QA Professionals of the Medical Device Industry!

Register Today !

     The European Regulations onMedical Devices (includingActive Implantable Medical Devices AIMD)– EU MDR 2017/745 –was published on May 5th, 2017 and entered into force on May 25th, 2017.With May 26th, 2020 as its application date,there is not a lot of time left for Medical Device companies to get up to speed. GMED North America has designed a comprehensive training course to help companies prepare for their application to obtain and/or maintain CE marking for their medical device product(s) and :

  • Gain an understanding of the changes introduced by both European Medical Device Regulation – EU MDR 2017/745;
  • Assess the impacts of those changes on their organizational and structural activities;

 

Over the course of 2 days, the attendees will learn about the new requirements to plan an efficient transition and ensure they are ready to:

  • Address the new Quality Management System (QMS) requirements;
  • Understand the Product Classification criteria’s and Conformity Assessment routes and how it applies to their device(s);
  • Assess the impacts on the Technical Documentation for Medical Devices in relation with Product Classification criteria’s and Conformity Assessment routes;
  • Identify the expectations with respect to the Clinical Evaluation, Clinical Data(s) and Risk Management;
  • Implement the requirements for labelling , the Unique Device Identification (UDI) and EUDAMED;
  • Address the expectations with respect to the requirements pertaining to the Post market Surveillance and Vigilance reporting (Periodic reports etc.);

 

     Sign up today and join our intensive 2 day course on the European Regulation for Medical Devices 2017/745 . Acquire a solid foundation so that you and your team are prepared to tackle through practical cases and working sessions/discussions led by our Expert lead auditor, these new challenges.

 

Keywords: European Medical Devices Regulation 2017/745, Quality Management System (QMS) , Essential Principles, Technical File Documentation, Regulatory Requirements, Compliance, Risk Management, Clinical Evaluation and Clinical Data, Post Market Surveillance, Vigilance reporting.

 

WHO SHOULD ATTEND

  • Medical Device Manufacturers: Senior Management , Regulatory Affairs Managers and Quality Managers, R& D specialists, Development, Manufacturing and Marketing Managers,
  • Internal and external Auditors
  • Importers
  • Distributors

 

REQUIRED LEVEL

  • Good knowledge and effective practice of the Directives 93/42 / EEC or /and 90/385 / EEC

 The maximum number of participants per training session is set to 15 to guarantee a stimulating and practical working environment.

 

EDUCATIONAL RESOURCES

  • Presentations in PDF:
  • Practical working sessions
  • Course evaluation
  • Lunch meeting with the trainer ( Lead Auditor and Technical File Assessor for high risk devices)

 

LEARNING OBJECTIVES

  • Understand the Medical Device Regulations approach in Europe
  • Know the expectations with the use of the Essential requirements
  • Understand how to read the Classification Criteria and Implementation rules
  • Learn how to identify:
    • the applicable conformity assessment routes for your device(s),
    • the impacts on the Technical Documentation
    • The expectations and requirements with regard to Clinical Data and Clinical Evaluation
    • Post market surveillance and reporting requirements in the MD

 

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

  • Practical working sessions
  • Group workshop
  • Course Evaluation
  • Summary and Discussion with the trainer

Register Today 

GMED 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 Bonfilou Color

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.

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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   1-301-495-0477

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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.