Deep Dive: Risk Management and ISO 14971

Categories: Deep Dive, EU, FDA
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About Course

We are currently revising this course. The updated version is expected in November 2024.

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A Deep Dive into Risk Management for medical devices. Underpinned by the ISO 14971 standard, these principles will be applicable to most global markets.

Risk management is an often misunderstood and underestimated aspect of medical device development. To ensure high quality products and patient safety, it is paramount that we appropriately consider and mitigate potential risks associated with our device, both throughout the design stages and after the device is on the market. This course will examine the ISO 14971 framework for risk management processes and activities, and more importantly, the practical application of this standard to build a robust, compliant risk management file for your device.

Written and developed by a group of Regulatory Affairs professionals currently working in industry, this course focuses on the most common issues and pitfalls we see from medical device manufacturers compiling their risk management documentation.

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What Will You Learn?

  • Learn about ISO 14971 and its role in risk management
  • Understand the ris management process flow and key aims
  • See first-hand how to compile risk management documentation
  • Learn how to maintain risk management files over the course of a device lifetime

Course Content

Introduction and Background
Welcome to the course! Before we begin, let's cover some of the essential background needed to get the most out of this course.

  • Welcome!
  • Instructor Tips
  • Course Scope

Risk Management Standards
Risk management is covered in a number of medical device standards. Notably, we have ISO 14971, but there are several others that place risk at their centre.

Risk Management Process
Let's start by clarifying some terms, and taking a high-level look at the overall process we want to follow

Risk Management Plan
Like any systematic process, we need to begin with a plan which defines the activities we will peform.

Hazard Analysis
The root of all risks is the potential for hazards. Let's learn about hazards, and how to systematically identify these for our device.

Risk Evaluation and Control
Risk Evaluation is central to the process. This is how we define the risks of our device, and the controls we will use to reduce risks

Residual Risk and Benefit-Risk Analysis
Understand the significance of Residual Risks, and the role that Benefit-Risk analysis plays in their mitigation

Risk Management Report
The final Risk Management Report should detail our findings and conclude whether the risks associated with our device are acceptable

Maintaing Risk Management
The Risk Management File is a living document which will be reviewed and revised throughout the device lifetime

Final Tools and Resources

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