Artificial Intelligence in Medical Devices: Regulatory Requirements
| Topic of the Course | Artificial Intelligence / Machine Learning in Medical Devices |
| Course Duration | 2 – 2.5 hours |
| Type of Course | e-Learning, Online & Self-Paced |
| Cost | 149,00 (VAT Excluded) |
Course Contents
Technical Documentation for AI-Based Medical Devices
Type of Machine Learning Models
Functionality & Performance
User Interface
Risk Management
Data Management for AI-Based Medical Devices
Requirements for Data Collection
Requirements for Data Annotation
Requirements for Data Processing
AI-Model Development
Requirements for Model Training
Requirements for Model Evaluation
Documentation for AI-Model Development within Medical Devices
Specific Requirements for AI-Based Medical Devices
Software Development
Risk Management
Instructions for Use
Usability Validation
Good Machine Learning Practice
Overview of the Good Machine Learning Practice issued by FDA and other competent authorities.
General Information
General Description
This online & Self-Paced Training Course is focused on the AI-Based Medical Devices, according to the requirements issued by FDA, Health Canada and IMDRF . 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 Artificial Intelligence and Machine Learning within medical device. The course is also specifically focused on practical aspects of technical documentation for AI-Based 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.
Structure of the Course
This course is divided into different sections. At the end of the whole training course, the possibility to perform a final quiz is given. A certificate of achievement will be issued, upon 70% of correct answers. The quiz can be related multiple times.
Course Certificate
At the end of the course, upon successful completion of the test. All tests 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.
