Course Introduction and Free Video Lesson
Live ISO 14971 Training
2h weekly live training sessions over 5 weeks
12 templates for creating a ISO 14971 compliant Risk Management File
Slides and Notes
More than 200 slides with extensive notes in downloadable PDF files
A certificate of competence in ISO 14971 requirements when you pass the final quiz with a passing grade of 80%
Feedback from Past Attendees
Senior Quality Engineer
I can tell that this course is State of the Art in regards to Risk Management knowledge. It has provided guidance to our Risk Management improvement effort and enhanced further the Risk Management knowledge we have.
Quality Management System/Quality Engineering/Regulatory (SaMD)
I am extremely satisfied with this course. It was far above my expectations. I understand the concept of Risk Management and I also like the way this course was presented (2 hours each day for 5 weeks).
The most useful part was to work with the case study and opportunity to ask questions. I feel extremely confident that I can begin applying this knowledge immediately
Senior Manager, Quality Systems
In the other risk management trainings the approach was very focus on going through the requirements in theory, I like this one because it was very practical and help us with an approach on how to achieve compliance to the standard.
Frequently Asked Questions
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Pre-register now for an upcoming session
There is a high demand for competent professionals who can help establish and maintain a compliant risk management system for medical devices. After completing this course, you will have the knowledge and tools available to build a risk management file for your medical device. This is a highly transferrable skills across the medical device industry.
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