Course Description

Preparing Risk Management File & Which Techniques Apply

Course Description:

This course addresses the basic structure and content of risk management files, including how to prepare them, which techniques to use, and when to apply each technique.

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Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Determine which elements to include in risk management files
  • Decide which risk management techniques to use and when
  • Apply specific techniques to risk management files

Who Should Enroll:

Clinical professionals involved in medical device life cycle strategies, clinical investigations directors, regulatory affairs coordinators, specialists, and managers, quality engineers, quality assurance managers, product development managers and leaders, and design and manufacturing engineers are all welcome to enroll in this course.

Prerequisite Knowledge/Requirements:

The following material is required:

  • ISO 14971: 2007 Review (ID 78)
  • ISO 14971: 2007 “Application of Risk Management to Medical Devices”

Subject Matter Expert:
Danielle Giroud

24 min

Related resources:

Case studies:

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Premium Account: € 55.00

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