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Enroll three students in the same course (held on the same date and at the same location) at the regular price and receive a fourth enrollment for free. *This offer cannot be combined with any other promotional offer(s).


Transition to the New EU Medical Device Regulation (MDR)

In May 2017, the European Union (EU) published two new regulations, one for medical devices (MDR) and another for in vitro diagnostic medical devices (IVDR). These regulations are the first major changes in the EU’s medical device regulatory environment in more than 20 years and will replace the three existing Medical Device Directives.

The new regulations are much tougher than the directives and promise to transform the way you do business in the EU.

In our new 2-day course, you will learn about the new requirements in the Medical Device Regulation (MDR), including those related to quality systems, product classification rules, technical documentation, clinical evaluations, Unique Device Identification (UDI), and postmarket surveillance; and learn how to plan an efficient transition.

Upcoming Dates and Locations

Please Contact Us if you need additional information or if you don't see a date that works for you. To register by phone, call 1.888.532.6360  |  On-Site training available, learn more »

Location Start Date Days Cost Public Course On-Site
Orlando, FL 01/08/2018 2 $2495.00 Add to Cart CONTACT US
Indianapolis, IN 01/22/2018 2 $2495.00 Add to Cart CONTACT US
Edison, NJ 02/05/2018 2 $2495.00 Add to Cart CONTACT US
Dublin, IE 02/05/2018 2 $2495.00 Add to Cart CONTACT US
Minneapolis, MN 02/19/2018 2 $2495.00 Add to Cart CONTACT US
San Jose, Costa Rica 02/26/2018 2 $2495.00 Add to Cart CONTACT US
San Francisco Area, CA 03/05/2018 2 $2495.00 Add to Cart CONTACT US
Frankfurt, DE 03/12/2018 2 $2495.00 Add to Cart CONTACT US
Boston, MA 03/26/2018 2 $2495.00 Add to Cart CONTACT US
Chicago, IL 04/09/2018 2 $2495.00 Add to Cart CONTACT US
San Diego, CA 04/23/2018 2 $2495.00 Add to Cart CONTACT US
Orlando, FL 05/14/2018 2 $2495.00 Add to Cart CONTACT US
Edison, NJ 05/21/2018 2 $2495.00 Add to Cart CONTACT US
Minneapolis, MN 06/04/2018 2 $2495.00 Add to Cart CONTACT US
Boston, MA 06/18/2018 2 $2495.00 Add to Cart CONTACT US
San Diego, CA 07/23/2018 2 $2495.00 Add to Cart CONTACT US

Course Objectives

  • Describe the objectives and structure of the MDR.
  • Identify the key new requirements in the MDR. 
  • Explain the impact of the new MDR requirements on economic operators, including manufacturers.
  • Identify the necessary steps to prepare an organization to transition to the MDR.
  • Learn how to conduct a gap assessment as part of the transition to the new requirements.

Course Topics

  • The objectives of the MDR
  • Quality management system requirements in the MDR
  • Device classification and conformity assessment routes changes in the MDR
  • Technical documentation requirements in the MDR
  • Clinical evaluation process requirements in the MDR
  • UDI and traceability requirements in the MDR
  • Postmarket surveillance and reporting requirements in the MDR
  • Life-cycle review of products linked to risk management and clinical evidence
  • Auditing impacts

Who Should Attend

Medical device professionals in areas of quality and regulatory affairs, design, risk management, postmarket activities, R&D, and manufacturing, who work for manufacturers that market devices in the EU. 

Number of Days: 2
CEUs: 1.5
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The dates you choose. The location you want.
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Bring any of our classes to your location - Oriel STAT A MATRIX on-site training is the perfect solution for training groups of five or more employees or launching a companywide training effort. It's cost-effective, completely customizable, and absolutely hassle-free. For more information, call 1.888.532.6360 or Contact Us.

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