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European Medical Device Regulation 2017/745

GMED North America, Inc.

Monday, March 25, 2019 at 8:30 AM - Tuesday, March 26, 2019 at 5:30 PM (PDT)

European Medical Device Regulation  2017/745

Ticket Information

Ticket Type Sales End Price Fee Quantity
Attendants (public) Mar 23, 2019 $1,900.00 $117.29
Attendants (early bird) Mar 5, 2019 $1,800.00 $111.20
Attendants (clients) Mar 23, 2019 $1,700.00 $105.12
Groups 3 person group Mar 23, 2019 $1,600.00 $99.03

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Event Details

 Training for RA/QA Professionals of the Medical Device Industry:

Implementing the European Medical Device MD 2017/745 Regulation

           The European Regulations on Medical Devices (including Active 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.

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

REQUIRED LEVEL

Good knowledge and effective practice of the Directives 93/42/ EECor /and 90/385 / EEC;

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)

Implementing the European Medical Device Regulation 2017/745

Day 1 & 2

8:30 am to 9:00 am – Breakfast;


9:00 am – 12:15 pm - Morning session

  • Regulation structure
  • Scope and Definitions
  • Actors and Responsibilities
  • Device Classification Criteria 
  • Conformity Assessment routes
  • Quality Management System requirements
  • Technical Documentation
  • Post Market Surveillance and Vigilance reporting requirements 
  • The Transition

12:15 pm – 1:00 pm - Lunch


1:00 pm – 5:00 pm - Afternoon session 

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

 


 

Client Testimonies

"The workshop was very beneficial for me. It provides training material I can use for my organization. It was good to collect ideas from others in the industry as I complete my gap analyses and begin formulating implementation plan for the changes needed."

Louise Miyamoto
Director, Quality Systems

"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


 

 Notes:

GMED North America, Inc. retains the right to cancel the training 7 days before the date if the number of attendees is insufficient.

Free parking is available on second floor of the parking garage located at the end of Bunker Hill Lane, 100 feet from the training location


 

Have questions about European Medical Device Regulation 2017/745? Contact GMED North America, Inc.

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When & Where


Academy X
5201 Great America Parkway
#254
Santa Clara, CA 95054

Monday, March 25, 2019 at 8:30 AM - Tuesday, March 26, 2019 at 5:30 PM (PDT)


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Organizer

GMED North America, Inc.

 GMED North America is the US subsidiary of GMED, the leading French Notified Body (CE0459), part of the LNE group, and an Accredited Certification and MDSAP Recognized Organization. 

We serve the medical device industry worldwide with offices in Europe and the United States. Our goal: Provide the best in Product Certification and Quality Management Services  through CE marking, ISO 9001:2015, ISO 13485:2016 and MDSAP.

 

With a long tradition in providing testing services like EMC and electrical safety testing for any of the European medical device standards, we also offer a full range of technical conformity services, from diagnostic audits to training, allows the convenience and efficiency of a local based team of technical experts, auditors and program managers and make us one of the leading European Notified Body. 

contact@lne-america.com

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