What You Will Learn
At the end of this workshop, you will be able to:
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Understand the drivers, requirements, intent, and impact of the EU IVDR.
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Evaluate the justification for risk-based device classification and conformity routes.
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Identify the requirements for economic operators, PRRC, and the role of common specifications.
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Assess the EU IVDR impact on quality management system requirements.
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Determine the relationship of EU IVDR requirements to 13485:2016 using CEN/TR 17223:2018.
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Evaluate EU IVDR requirements related to risk management, GSPRs, technical documentation, UDI, performance evaluation, and postmarket surveillance.
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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.
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
Virtual Half-Days:
5
In-Person Full-Days:
4
CEUs:
2.8