EU IVDR Auditor Training

What You Will Learn

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

• Understand the drivers, requirements, intent, and impact of the EU IVDR.
• Evaluate the justification for risk-based device classification and conformity routes.
• Identify the requirements for economic operators, PRRC, and the role of common specifications.
• Assess the EU IVDR impact on quality management system requirements.
• Determine the relationship of EU IVDR requirements to 13485:2016 using CEN/TR 17223:2018.
• Evaluate EU IVDR requirements related to risk management, GSPRs, technical documentation, UDI, performance evaluation, and postmarket surveillance.
• Evaluate objective evidence, build audit checklists, and devise auditor questions while using a case-study approach to simulate an internal audit to EU IVDR.

Who Should Attend

Internal and corporate auditors, personnel participating in audits, and those performing gap assessments to the new EU IVDR. Participants are expected to have practical experience in auditing, awareness of the EU IVDR, and a working knowledge of ISO 13485 and ISO 14971.

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.

Pre-Work

In advance of the workshop, course participants are required to complete one short (~ ½ hour) eLearning module covering basic topics related to EU IVDR. 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. Access to the eLearning module is provided to course participants the week before the start of the class.

Course Days

Virtual Class Days: 5 days, Mon - Thurs daily 1:00 - 5:00 p.m.; Fri 11:30 a.m. - 5:00 p.m.

Classes run either on Eastern Time or Central European Time as indicated in the virtual class "Location" field

Related Courses

• Implementing the EU's New In Vitro Diagnostic Regulation Training (IVDR 2017/746)
• EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745)

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; the Friday session runs 11:30 a.m.-5:00 p.m. to allow time for administering the final exam.
  • Classes run either on Eastern time or Central European time as indicated in the virtual classs "Location" field
• 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.