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ISO 18969 – Clinical Evaluation and Post-Market clinical follow-up (PMCF)

This course provides an in-depth overview of ISO 18969 requirements for the planning and management of Clinical Evaluation activities in accordance with the MDR.

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 ISO 18969 requirements for the planning and management of Clinical Evaluation activities in accordance with the MDR. It offers practical guidance to structure a systematic clinical evaluation process and integrate it into the post-market surveillance system throughout the device lifecycle.

Key Points

  • Clinical evaluation (ISO 18969 / MDR)

  • Planning and management

  • Systematic evaluation process

  • PMCF integration

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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