Risk Management ISO 14971 training

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.

Costs

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.