General Information
| Topic of the Course | Risk Management for Medical Devices |
| Course Duration | 1-1,5 hours |
| Type of Course | e-Learning, Online & Self-Paced |
| Course Material Available | No (upon request) |
| Transcript Available | No (upon request) |
Course Contents
Introduction to Risk Management
Introduction to Risk Management
Risk Management Plan
Risk Management File
Risk Management Process
Risk Analysis
Risk Evaluation
Risk Control
Risk Acceptability
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 Risks Management Process for medical devices, according to the requirements of EN ISO 14971, ISO 24971 and EU MDR 2017/745 . 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 involved in the design of medical devices and in the risk management process.
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.
Structure of the Course
This course is divided into four different sections. At the end of each session, there are some tests and exercises aimed at consolidating the information related to each part of the course. At the very end of the course, a final test shall be performed.
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.
