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

This interactive, case study-based training will prepare you to audit to EU MDR requirements using real-life scenarios and examples.

As of May 26, 2021, device manufacturers who conduct business in the EU and do not have a valid MDD certificate must now follow EU's new Medical Device Regulation. Many Notified Bodies are refusing to conduct an EU MDR certification audit for device manufacturers who can't demonstrate they have performed their own internal audit against the EU MDR requirements.

Designed for experienced auditors who are already familiar with ISO 13485:2016 and ISO 14971, course attendees will gain the knowledge and experience needed to perform internal and supplier audits to the EU MDR requirements.

This instructor-led online or in-person class is for experienced auditors who need to learn how to perform audits to the EU MDR requirements. If you need a foundation in the EU MDR, choose our EU MDR Implementation Training class instead.

Upcoming Dates and Locations

Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.

Location Start Date Days Cost Public Course Private
VIRTUAL DELIVERY (Eastern Time) 11/29/2021 5 $3295.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (Eastern Time) 01/17/2022 5 $3295.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (Eastern Time) 02/28/2022 5 $3295.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (Eastern Time) 03/28/2022 5 $3295.00 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 ISO 14971.

Pre-Work

In advance of the virtual workshop, course participants are required to complete one short (~ ½ hour) eLearning module covering basic topics related to EU MDR. Completion of this module helps to level-set course attendees, ensuring familiarity with key course topics and an ability to hit the ground running on the first day of class. The eLearning module is provided to course participants as part of the virtual training classroom, which is sent the week prior to the start of class.

Exemplar Global Certification

Oriel STAT A MATRIX is a registered training provider for Exemplar Global. Students who achieve a passing grade on the course’s final exam will earn both a certificate recognized by Exemplar Global as evidence of your competency as well as an Oriel STAT A MATRIX credential in assessing proficiency.

Virtual Half-Days: 5
In-Person Full-Days: 4
CEUs: 2.8

Virtual Session Details

The learning objectives and topics covered during VILT are the same as those for the in-person version of the course. To accommodate the VILT format, classes are delivered at a pace well suited to virtual instruction, and the structure of class workshops and exercises has been modified to work best in the virtual environment.  Each VILT session is a combination of subject matter expert and group discussions, interactive whiteboards, polls, and chat rooms that help students with small group exercises, making this an engaging, interactive learning experience.

Online Training Schedule

  • This class is delivered across 5 consecutive half-days.
  • Monday-Thursday sessions run 1:00-5:00 p.m. Eastern time; the Friday session runs 11:30 a.m.-5:00 p.m. ET to allow time for administering the final exam.  
  • This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

See course dates to find / register for a virtual online session of this course.

VIRTUAL CLASS TIMES Close

Public virtual seminars run daily from 1:00-5:00 p.m. ET. Seminars run on Eastern Time unless otherwise noted in the Location field.

Auditor classes that require a final exam start at 11:30 a.m. on the last day to administer the final exam.

For more information download the virtual course agenda (close this window and navigate to the top of the course page) or Contact Us.

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