Certification in Fundamentals of Risk Management 

If you are new to risk management of medical devices, this online ISO 14971 training course will help you master 25 key terms and basic concepts. This foundational knowledge will help you in implementing an ISO 14971 compliant risk management process. 

Risk Management Fundamentals Course

Clear Definitions

Each term is clearly defined according to ISO 14971:2019, the standard for risk management

Illustrative Examples

Examples clarify how each term may be consistently used without any confusion

Regulatory Requirements

Regulatory requirements and expectations for each term are outlined

Course Certificate

A certificate of competence will be issued if you pass the final quiz with a passing grade of 80%

Course Introduction and Sample Video Lesson

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Feedback from recent students

Maki I.

"I learned a lot through the course. It was very clearly explained with videos and beneficial slides. I liked the way that the videos were split into 10 minutes. I could concentrate on one topic very well and quickly review what I could not understand. Excellent construction of the course! The last quizzes were challenging for me. But thanks to the quiz, I could watch the videos, review the topics again, and fully understand. Thank you so much!"

Robert R.

"Thank you for compiling the “Fundamentals of Medical Device Risk Management”! I am convinced that this course will help me start out as a Risk Management Specialist in my company. I really like your approach of linking the key terms from different levels to each other to get a big picture in the end. I will definitely recommend this course to other new colleagues as they start their journey in risk management"

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Great Content at Affordable Cost!

Over 3h of Video Lessons

25 key terms are organized in 5 modules. Each term is covered in a 5-10 min long video lesson

Over 150 Slides with Notes

Each module has a downloadable PDF with extensive notes for additional guidance 

Practice Quizzes

Practice quizzes after each module to help you retain knowledge and pass the final quiz for certification

Bonus Content

A free Excel based template for doing Preliminary Hazard Analysis (PHA) in Module 4

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Frequently Asked Questions

Start strong and grow your career in risk management 

Risk management of medical devices is challenging. Completing this foundational course will help you build a solid understanding of key concepts, avoid confusion in implementation, and establish a world-class risk management process for your medical device. Start strong to build a successful career in risk management through this ISO 14971 training!

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