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

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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).


EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745)

This class is for experienced auditors who need to learn how to perform audits to the EU MDR requirements. If you need to get a foundation in the EU MDR, choose our EU MDR Transition Training class.

If you sell devices in Europe and have responsibility for internal and/or supplier audits within your company, this course is tailor-made for you. 

Our interactive, case study-based training will prepare you to audit to EU Medical Device Regulation requirements using real-life scenarios and examples.

Designed for experienced auditors who are already familiar with ISO 13485 and ISO 14971, course attendees will gain the knowledge and experience needed to perform internal and supplier audits to the EU MDR requirements.

The course is certified by Exemplar Global under their Exemplify process. Students who achieve a passing grade on the course’s final exam will earn a numbered certificate with the Exemplar Global stamp that can be used as evidence of your competency, as well as Oriel STAT A MATRIX credentials in assessing proficiency.

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 07/30/2019 4 $2995.00 Add to Cart CONTACT US
Raleigh, NC 08/13/2019 4 $2995.00 Add to Cart CONTACT US
Irvine, CA 08/20/2019 4 $2995.00 Add to Cart CONTACT US
Minneapolis, MN 09/10/2019 4 $2995.00 Add to Cart CONTACT US
Edison, NJ 09/24/2019 4 $2995.00 Add to Cart CONTACT US
Austin, TX 10/08/2019 4 $2995.00 Add to Cart CONTACT US
San Diego, CA 10/22/2019 4 $2995.00 Add to Cart CONTACT US
Orlando, FL 11/05/2019 4 $2995.00 Add to Cart CONTACT US
San Jose, Costa Rica 11/19/2019 4 $2995.00 Add to Cart CONTACT US
Chicago, IL 12/03/2019 4 $2995.00 Add to Cart CONTACT US
Boston, MA 12/10/2019 4 $2995.00 Add to Cart CONTACT US

What You Will Learn

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

  • Understand the drivers, intent, and impact of the EU MDR.
  • Articulate the relationship between the EU MDR, ISO 13485:2016, and CEN/TR 17223:2018.
  • Craft a plan for how to conduct EU MDR gap assessments and perform a comprehensive audit.
  • Evaluate objective evidence using a case study approach to simulate an internal audit to the EU MDR.
  • Explain the relationship to MDSAP and FDA audits and differences between them.
  • Gain a comprehensive understanding of how to audit to specific EU MDR requirements, with emphasis on the following areas:
    • Technical documentation, including clinical data and risk management files
    • Product classification and conformity assessment route
    • Postmarket surveillance processes
    • QMS and ISO 13485:2016 compliance
    • Unique Device Identification and traceability requirements

Who Should Attend

Internal regulatory and QMS auditors, personnel participating in audits, and those performing gap assessments to the new EU MDR. Participants are expected to have practical experience in auditing, awareness of the EU MDR, and a working knowledge of ISO 13485:2016 and EN ISO 14971:2012.

Number of Days: 4
CEUs: 3
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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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