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.

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.