Risk Management ISO 14971 training

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Risk Management for Medical Devices ISO 14971

Supplementary training is often overlooked by medical device professionals until it is triggered by an upcoming Notified Body and/or ISO 13485 certification audit. Our experts all have many years of “real” experience in their own particular areas of the Medical Device Industry, ensuring your company a high-quality training session.


Program overview

Duration: 1 day

  • Relation of Risk Management with ISO 13485
  • Concepts and definitions of Risk Management
  • Stages of the Risk Management process
  • Use of the various annexes of ISO 14971 during the stages in the Risk Management process
  • Product Risk Analysis: use of Failure Mode and Effect Analysis
  • Risk Management report
  • Questions & Answers
  • Evaluation of the course and Closing

Learning Objectives

  • Understand and explain the basic concepts of Risk Management
  • Explain the Risk Management Process in relation to the Product Lifecycle
  • Understand and use the stages in the Risk Management Process
  • Apply Failure Mode and Effect Analysis on a Medical Device

Who should attend?

  • Senior Management
  • Quality Managers and Regulatory Affairs Managers
  • Product Developers and Product Managers
  • Members of Risk management teams
  • Anyone involved with the implementation of Medical Devices to the market

The number of participants is maximized to nine to provide a stimulating and practical working environment.


We offer open enrolment, on-location, train-the-trainer formats.

Please contact us to schedule in-house training, which is also recommended for training multiple colleagues or teams at the same time.