On completion, successful Learners will have the knowledge needed to:
- Explain what is meant by risk management and outline its role throughout the product lifecycle
- Describe the purpose, history, and structure of ISO 14971
- Define the key terms used throughout ISO 14971
- Outline the relationship between ISO 14971 and the US FDA and EU medical device regulations
- Outline the relationship between ISO 14971 and the common medical device product and process standards
Successful completion will entitle each Learner to receive a digital Certificate of Completion.
Who should attend?
- Anyone interested in Medical Device Risk Management / ISO 14971
- Quality Engineers
- QA/RA Personnel
In order to successfully complete this eLearning course, each Learner will need to:
- Complete the eLearning course modules and obtain 70% or higher in the final assessment (MCQ-based)
Upon registering for this course, each Learner will have 30-days of eLearning access to complete the course.
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.
Click here to read the full technology requirements.
- Your Computer System and EquipmentYou are solely responsible for supplying all equipment, Internet access, and bandwidth needed to properly access and use the Course. Before paying for (or being provided with access to) any Course, You must confirm the compatibility of your computer system with the published computer specification for the applicable Course. COMPLY GURU shall have no responsibility or liability for Your inability to access the Course due to issues beyond COMPLY GURU’s control, including but not limited to the speed of Your modem – or other connection devices used, Your use of third-party security software or firewall/proxy servers, or the performance levels of Your internet service provider.
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