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A customizable, cost-effective solution for groups of 5 or more. Contact us to learn more »

On-site TrainingGroup Discount Save up to 25%

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).

New! 

EU IVDR Transition Training (Europe’s In Vitro Diagnostic Regulation 2017/746)

The changes under Europe’s new IVD regulation are significant, including the need for Notified Body involvement, a greatly expanded definition of what is considered an IVDR, a new risk-based IVD classification system, increased clinical evidence requirements, new quality system mandates,  and more rigorous postmarket scrutiny.

IVD manufacturers who conduct business in the EU must start their transition now in order to meet the May 26, 2022 transition deadline. This course is a critical first step. In this class you’ll learn about the significant new requirements found in the IVDR, their impact on manufacturers, and how to plan an effective and efficient transition to the IVDR.

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 1.800.472.6477  |  On-Site training available, learn more »

Location Start Date Days Cost Public Course On-Site
San Francisco Area, CA 08/20/2019 3 $2995.00 Add to Cart CONTACT US
Boston, MA 09/17/2019 3 $2995.00 Add to Cart CONTACT US
Orlando, FL 10/15/2019 3 $2995.00 Add to Cart CONTACT US
Chicago, IL 11/12/2019 3 $2995.00 Add to Cart CONTACT US
San Diego, CA 12/03/2019 3 $2995.00 Add to Cart CONTACT US
Edison, NJ 01/21/2020 3 $2995.00 Add to Cart CONTACT US
Minneapolis, MN 02/11/2020 3 $2995.00 Add to Cart CONTACT US

What You Will Learn

At the end of this workshop, participants will be able to:

  • Describe IVDR objectives and structure, and identify key differences between the IVDD and IVDR.
  • Explain the impact of the new IVDR requirements on economic operators, including manufacturers.
  • Describe the various regulatory requirements through the life cycle of a device (e.g., premarket, design and development, product realization, and postmarket).
  • Explain new stipulations for the clinical evaluation process and risk management, including performance evaluation.
  • Understand new device classification rules plus technical documentation, UDI, and traceability specifications.
  • Articulate postmarket surveillance and reporting mandates in the IVDR.
  • Identify the steps needed to prepare an organization to transition to the IVDR.
  • Plan a gap assessment to transition an organization to compliance and understand the impact on internal auditing.

Who Should Attend

Anyone who works for manufacturers that market in vitro diagnostics in the EU.

Number of Days: 3
CEUs: 2.5
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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 1.800.472.6477 or Contact Us.

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