Medical Device Risk Management Course
| Topic of the Course | Clinical Evaluation |
| Course Duration | 1.5 – 2 hours |
| Type of Course | e-Learning, Online & Self-Paced |
| Cost | 89,00 (VAT Excluded) |
Course Contents
Introduction to Risk Management
Terms and Definitions
Introduction to ISO 14971
Risk Management Process
Risk Analysis
Risk Evaluation
Risk Control
Deep dive into specific aspects of Risk Management
Risk Management and Cybersecurity
Further guidance on risk analysis and risk estimation
Probability of occurrence and sequence of events
Risk Management, Clinical Evaluation, Post-Market Surveillance
Post-market Risk Management
Risk management and Clinical Evaluation
Benefit Risk Analysis
General Information
General Description
This online & Self-Paced Training Course is focused on the Risk Management for medical device, according to the requirements of ISO 14971 and ISO/TR 24971. For a more detailed description of the course, refer to the section related to the course contents.
Who Should Attend the course?
This course should be followed by anyone interested in the risk management process for medical devices.
Course Access
You need to register before to have access to the course. Registration can be performed at this link; once the registration is successful, you will redirect automatically to the page listing all the courses.
Course Certificate
At the end of the course, upon successful completion of all the intermediary and test. Each test shall be passed with a minimum score of 70%.
Prerequisites
No specific prerequisites are requested to attend this course. However, general knowledge of ISO 13485 and EU MDR / IVDR would be beneficial, although not mandatory or requested.
