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Master ISO 14971 – Risk Management for Medical Devices
Learn how to identify, analyze, and control risks in medical devices – and apply ISO 14971 in real projects
149,00€
2h video training 50+ pages training material 60 days access (Single license)
What you'll learn
- Understand the complete ISO 14971 risk management process
- Learn how to identify hazards and hazardous situations
- Perform risk analysis and risk evaluation step-by-step
- Apply risk control measures effectively
- Understand residual risk and benefit-risk evaluation
- Learn how to document risk management activities
- Avoid common mistakes in real medical device projects
- Prepare for audits and regulatory compliance
Course Preview: Get a Real Insight into the Training
Description
Medical devices must meet strict safety and regulatory requirements. ISO 14971 is the globally recognized standard for risk management in medical device development.
This course provides a clear and practical introduction to ISO 14971 and shows how risk management is applied in real-world projects. You will learn how to systematically identify hazards, analyze risks, and implement effective risk control measures throughout the product lifecycle.
Instead of focusing only on theory, this course explains how risk management activities are actually performed in practice – from initial risk analysis to post-production monitoring. You will also understand how to evaluate residual risks and ensure compliance with regulatory expectations.
By the end of this course, you will be able to apply ISO 14971 in your own projects and understand how companies ensure safe and compliant medical devices.
Course content
Introduction
- Introduction & Agenda
- Motivation
Basics of Risk Management
- Fundamentals of ISO 14971
- Risk management process overview
Risk Analysis
- Hazard identification
- Risk estimation
Risk Evaluation
- Risk acceptance criteria
- Decision-making process
Risk Control
- Risk reduction measures
- Implementation and verification
Residual Risk & Review
- Evaluation of overall residual risk
- Risk management review
Production & Post-Production
- Monitoring in real-world use
- Feedback and continuous improvement
Common Practical Challenges
- Typical mistakes in ISO 14971 implementation
- How to avoid compliance issues
Trusted by 12,000+ Engineers
From 100+ Countries
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Rohan Arora
“Great introduction to the most relevant parts of ASPICE. Totally recommended for beginners!“
Jose F. Gonzalez A.
“Great overview of ASPICE!”
Veselina Demireva
“The course is very structured and is based on the chapters of ISO 21434, which helped me a lot to compare the content of the course with the standard. This course is highly recommended for an initial overview of ISO. The content is clearly explained and easy to understand.”
Markus Simon
“The course has broken down a rather tough topic into a simpler words by connecting the right dots.“
Priyanka Pacharne
“Amazing, above expectations!“
Asfiyan Ali Khan
“I am coming to this program with 20+ years of experience with MIL-STD-882. This class allowed me to see what I would need to change in order to transition from 882 to ISO 26262. Overall, I thought this was a good presentation. I think the class provides a good overview for both the novice safety engineer and the old and crusty veteran. The class brought out many topics that forced me to go back to my old standard”
Patrick Norris
“Over all the course was really amazing with usefull information”
Prashanth Chotu
Looking for a complete medical device training?
Get access to all essential medical device standards in one structured learning path – from risk management to quality and software compliance
Build a solid foundation in medical device development by combining risk management, quality management, and software standards in one training.
This bundle includes:
- ISO 14971 – Risk Management for Medical Devices
- ISO 13485 – Quality Management Systems
- IEC 62304 – Medical Device Software
Medical Devices Engineering Bundle – All Courses in One
Build a complete understanding of medical device regulations and standards – and apply them in real projects
447,00€ 249,00€
Save 44%
✔ 8+ hours of video training
✔ 200+ pages of training material
✔ 60 days access (Single license)
✔ Practical examples and real-world use cases
✔ Quizzes and structured learning path