European Medical Device Regulation 2017/745

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Location

GMED North America

6550 Rock Spring Drive, Suite 280

Bethesda, MD 20817

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Refunds up to 7 days before event

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Description

The new European Union Medical Device Regulation (MDR 2017/745) represents a considerable change from the directives. Medical Device Manufacturers who sells their medical devices in the European Union have taken the necessary steps towards the transition to meet the deadline of May 26, 2020, date that will mark the end of the transition period. This course is a first step towards understanding how to assess the impacts the new regulation implies over your activities and organization. Compliance with the European MDR in a timely manner is the key to implementing it successfully and calls for a structural approach. Over 2 days, attendees will discover and learn about the new requirements to plan an efficient transition and ensure they are ready to address the new Quality Management System (QMS) requirements, the Product Classification criteria’s and Conformity Assessment routes, the impacts on the Technical Documentation for Medical Devices, the expectations with regard to the Clinical Evaluation and Clinical Data, the Unique Device Identification (UDI), and the Post market Surveillance and Vigilance reporting requirements.

Join us for an intensive 2-day course on the European Medical Device Regulation 2017/745 and acquire the solid foundation you and your team need to tackle this new challenge. Through practical cases, working session and discussion with a seasoned lead auditor, prepare for the new Regulation 2017/745.

Keywords: European Medical Device Regulation 2017/745, Essential Principles, Technical File Documentation, Regulatory Requirements, Compliance, Risk Management, Clinical Evaluation and Clinical Data, Post Market Surveillance, Vigilance.

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 number of participants is maximized to fifteen to provide a stimulating and practical working environment.

EDUCATIONAL RESOURCES

  • Presentations
  • 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

DAY 1 & 2: European Medical Device Regulation 2017/745

8:30 am to 9:00 am - Breakfast
9:00 am – 12:15 pm:

  • 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:

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


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

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OUR CLIENTS SAY:

"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

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Date and Time

Location

GMED North America

6550 Rock Spring Drive, Suite 280

Bethesda, MD 20817

View Map

Refund Policy

Refunds up to 7 days before event

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