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ISO 14971 Requirements Training for Practitioners and Auditors that provides a comprehensive overview of the international standard for risk management for medical devices. This course has been specifically designed for Quality & Regulatory Professionals in the Medical Device Industry.
Our online training is a highly interactive way to learn at a time & pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.
Course Structure Explained
eLearning Module Breakdown & Timings
An interactive, engaging eLearning experience that you can complete Anytime, Anywhere.
| Time | Topic |
|---|---|
| 75mins eLearning | Module 1: Introduction to Risk Management
|
| 90mins eLearning | Module 2: Risk Management Planning
Case Study! Elements of a Risk Acceptability Policy |
| 120mins eLearning | Module 3: Risk Assessment
Case Study! Safety Characteristics Case Study! Hazard Identification and Sequence of Events |
| 90mins eLearning | Module 4: Risk Control
Case Study! Benefit Risk Analysis Case Study! Overall Residual Risk |
| 75mins eLearning | Module 5: Risk Management Review and Update
Case Study! Post-Market Surveillance and Risk |
| 90mins eLearning | Module 6: ISO/TR 24971
|
| 40mins | Certification Exam
|
Course Overview
ISO 14971 Requirements Training
Explain the history, purpose, and structure of ISO 14971 and its relationship to ISO 13485 and the EU & US FDA regulations
Define the key terminology used throughout ISO 14971
Describe the elements of an effective risk management process
Describe the different techniques that support risk analysis
Explain the requirements for updating the risk assessment based on information collected and reviewed
Outline the role of ISO TR 24971 in risk management
This course is aimed at anyone working in the medical device sector that wants to gain an understanding of risk management based on ISO 14971, including:
- Design & Development personnel
- Quality / Engineering / Technical / Production personnel
- Regulatory affairs
- Internal / Lead / Supplier Auditors
CQI & IRCA certify this course (No. 2415). Upon successful completion, each Learner shall receive a digital Certificate of Completion within 1 business day.
Before completing this course, each Learner is recommended to have the following prior knowledge:
- The fundamental concepts and principles of risk management as it applies to medical devices
- The commonly used risk terms and definitions (see ISO 14971)
- A working knowledge of ISO 13485, which may be gained by completing Comply Guru’s ISO 13485 Foundation Course
In order to successfully complete this course, each Learner will need to:
- Complete the eLearning modules and obtain 70% or higher in the final assessment (MCQ-based)
There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.
Why Choose Comply Guru
About our ISO 14971 Foundation Training
Learn about how our Globally Recognized ISO 14971 Training is leading the industry for innovation through online learning
Customer Reviews
What Our Learners Are Saying
Read verified reviews from Learners who have completed this course.
4.4
Average Rating
438 global ratings
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Excellent course, good content and well paced
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Engaging course on a topic I did not know alot about.
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Very comprehensive, gained some valuable knowledge
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It took a lot of time but was very informative and helpful.
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Love the e-training and the flexibility that it offers and that I can do it on my own time. This is what makes me select ComplyGuru trainings.
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