Risk Management for Medical Devices and ISO 14971

Course Description:

This course highlights the particular importance of Risk Management practices throughout the medical device development lifecycle. From the very basic elements of vocabulary to the concepts of risk Assessement and Controls, learners will gain an understanding of why Risk Management is so important, and how to go about implementing it at their organization. 

This content is great for quality, regulatory, and product development personnel who need to have the context and understanding of Risk Management in mind as they go about the work of including Risk Management in their company's processes and procedures. It's also ideal for those who are new to the medical device industry, or leadership who need to quickly get up to speed on concepts and terminology to have effective conversations about risk at work. 

Course Information:

Learners may complete this training at their own pace, whether they prefer taking breaks between sections, or finishing in one sitting. We have found that the course takes approximately 4-8 hours to complete. The content is a combination of video, quizzes, and interactive elearning elements that will inform while also keeping the learner engaged throughout the process. 

Learners will take a final exam at the end of the course. The final exam is made up of 50 questions and learners will have two attempts to score a passing grade. Upon completion of the exam, a certificate will be delivered to the learner's email that includes all necessary data to prove completion and that they have earned this credential. 

Time: 4-8 hours

Continuing Education Credits (CEU): 1

Access: 1 year from registration to complete