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

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

The clock is ticking for In Vitro Diagnostic (IVD) manufacturers. If you are a manufacturer who conducts business in the EU, you must start your transition now in order to meet the May 26, 2022 transition deadline. Your internal auditors will be critical resources in the transition.

This course uses a case-study approach to prepare participants to audit to the EU IVDR. This course uses a case-study approach to prepare participants to audit to the EU IVDR. It is designed for auditors with experience auditing to ISO 13485 but will also help auditor-facing personnel prepare for Notified Body audits.

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
Boston, MA 10/06/2020 4 $3295.00 Add to Cart CONTACT US
Orlando, FL 10/20/2020 4 $3295.00 Add to Cart CONTACT US
Minneapolis, MN 11/10/2020 4 $3295.00 Add to Cart CONTACT US
San Diego, CA 12/08/2020 4 $3295.00 Add to Cart CONTACT US

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.

In-Person Days: 4
CEUs: 2.8

Public virtual seminars run daily from 1:30-5:00 p.m. EST (3.5 hours each day).

Auditor classes that that require a final exam are extended by 2 hours 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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