Udemy – Applying ISO 14971 Risk Management to Medical Devices 2025-2

Applying ISO 14971 Risk Management to Medical Devices course. This comprehensive course teaches you how to use the AAMI/BSI TR 34971 and ISO 14971 standards to manage risk in AI-enabled medical devices. You will learn how these global frameworks ensure safety, compliance, and quality throughout the product lifecycle. By focusing on AI-specific challenges such as algorithmic bias, model switching, and data integrity, participants will gain valuable insights into mitigating risks associated with AI technologies in healthcare.

What you will learn:

• Understanding the specific risk management of AI in medical devices: Gain an in-depth understanding of the unique challenges and risks associated with AI-based medical devices.
• Understanding the legal requirements for AI-based medical devices: Learn about the laws and regulations related to AI-based medical devices and how to comply with them.
• Implementing a Comprehensive Risk Management Process: Learn how to create and implement a comprehensive risk management process for AI-based medical devices.
• Identify and mitigate AI-specific risks: Learn how to identify and mitigate risks such as algorithmic bias and model switching.
• Ensure post-sale monitoring and continuous improvement: Understand the importance of monitoring the performance of devices after they enter the market and continuously improve risk management processes.

Who is this course suitable for?

• Regulatory professionals: Individuals working in medical device regulatory compliance who need to understand the application of ISO 14971 and AAMI/BSI TR 34971 standards to manage specific AI risks.
• Quality Assurance and Risk Management Professionals: Professionals responsible for ensuring the safety, quality, and performance of medical devices and who want to implement a comprehensive risk management process for AI-based devices.
• Medical Device Developers and Engineers: Engineers and developers involved in creating or updating AI-based medical devices and want to gain important insights into how to identify and mitigate AI-specific risks such as algorithmic bias and model switching.
• Healthcare and AI enthusiasts: People who are interested in AI and healthcare innovation and want to learn about the intersection of AI technology with medical device regulations, safety standards, and risk management.

Course details: Applying ISO 14971 Risk Management to Medical Devices

• Publisher:  Udemy
• Instructor:  eQMS Innovation
• Training level: Beginner to advanced
• Training duration: 1 hour and 4 minutes
• Number of lessons: 13

Course headings

Prerequisites for the Applying ISO 14971 Risk Management to Medical Devices course

• Basic Understanding of Medical Devices and AI Learners should have a fundamental understanding of medical devices and how artificial intelligence (AI) is used in healthcare applications. Familiarity with basic AI concepts, such as machine learning models and their applications, is helpful but not mandatory.
• Familiarity with Risk Management Principles Some experience with risk management or quality assurance processes (in any industry) would be beneficial. This includes concepts like risk assessment, mitigation strategies, and compliance.
• Eagerness to learn No prior experience with ISO 14971 or AAMI/BSI TR 34971 is required. Beginners are welcome, and the course will cover all key concepts, standards, and practices needed to understand and manage risk in AI-based medical devices.

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338 MB