Overview - Medical Devices (iso 14971:2019)
 

Medical devices - Application of risk management to medical devices
What you'll learn
✓ Explain the purpose, scope, and regulatory relevance of ISO 14971 for medical device risk management.
✓ Describe the structure and key elements of the risk management process defined in ISO 14971.
✓ Identify hazards, hazardous situations, and potential harms associated with medical devices.
✓ Understand the principles of risk analysis, risk evaluation, and risk control.
✓ Explain how risk acceptability is determined and documented within a risk management framework.
✓ Understand the concept of residual risk and the evaluation of overall residual risk.
✓ Describe the role of risk management throughout the product lifecycle, including production and post-production activities.
✓ Recognize how ISO 14971 supports communication between engineering, quality, clinical, and regulatory teams.
Requirements
● No prior knowledge required
Description
This course contains the use of artificial intelligence.
This online video course offers a comprehensive yet accessible introduction to the ISO 14971 standard, the internationally recognized guideline for risk management of medical devices. The course is specifically designed for beginners who have little or no prior experience with ISO 14971 and who are looking for a clear, structured overview rather than in-depth technical training.
Throughout the course, learners will gain an understanding of the purpose and background of ISO 14971 and its role in ensuring the safety of medical devices throughout the entire product lifecycle. The course explains how ISO 14971 fits into the broader medical device regulatory environment and how it supports compliance with regulatory expectations worldwide. Key concepts such as hazard identification, risk analysis, risk evaluation, risk control, residual risk assessment, and the overall risk management process are introduced in a clear and practical manner.
The course focuses on explaining what ISO 14971 requires and why these requirements exist, rather than how to implement them within a specific company process. Detailed procedural implementation and company-specific documentation approaches are intentionally kept at a high level to ensure the content remains accessible to newcomers.
By the end of the course, participants will be familiar with essential ISO 14971 terminology and principles and will understand the expectations placed on development teams working on regulated medical device products. This foundational knowledge will help learners communicate more effectively with engineering, quality, and regulatory professionals and will prepare them for further, more advanced training on medical device risk management.
This course is ideal for engineers entering the medical device domain, project managers, quality and regulatory professionals, and anyone seeking a solid introductory overview of the ISO 14971 standard.
Who this course is for
■ Engineers working in medical device development (hardware, software, or systems)
■ Quality assurance and regulatory affairs professionals
■ Risk management and safety engineers
■ Project managers involved in medical device projects
■ Professionals transitioning into the medical device industry
■ Anyone seeking a structured introductory overview of the ISO 14971 standard