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Complaint Management, Regulatory reporting, and vigilance

This course provides an in-depth overview of complaint management and vigilance reporting, analyzing regulatory requirements, timelines, and responsibilities, with a focus on MDR (EU) 2017/745 and IVDR (EU) 2017/746.

This course belongs to the “Post-Market & Clinical Evaluation” line.

Contact our team if you would like a complete training package covering all related topics, or to request a tailored solution.

Abstract

This course provides an in-depth overview of complaint management and vigilance reporting, analyzing regulatory requirements, timelines, and responsibilities, with a focus on MDR (EU) 2017/745 and IVDR (EU) 2017/746. Through practical exercises, it offers operational guidance for correctly preparing reports and managing responses to Competent Authorities.

Key Points

  • Complaint management and vigilance

  • Regulatory requirements and timelines

  • MDR and IVDR focus

  • Reporting and authority responses

Structure

8-hour course.

Live streaming or on-site at your company, based on your needs.

Would you like to host this course at your company?

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