General Information
Introduction to Usability
Terms and Definition
ISO standard related to Usability
FDA requirements
Usability Evaluation Process
Usability Engineering Process
Instructions for Use and Risk Management
Use Specification
User Interface Characteristics
Usability & Risk Management
Hazards and Hazardous Situations related to Usability
User Interface Evaluation Plan
Formative & Summative Evaluation
Usability Testing
Simulated Use Human Factor Validation test
Characteristics of the participants
Type of data collected through Usability Test
General Information
General Description
This online & Self-Paced Training Course is focused on the Usability Evaluation for medical devices, according to the requirements of EN ISO 62366, and EU MDR 2017/745 and FDA guideline . 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 different sections, each of the them covering specific topics as outlined in the course contents page.
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.
Course Contents
Introduction to Usability
Terms and Definition
ISO standard related to Usability
FDA requirements
Usability Evaluation Process
Usability Engineering Process
Instructions for Use and Risk Management
Use Specification
User Interface Characteristics
Usability & Risk Management
Hazards and Hazardous Situations related to Usability
User Interface Evaluation Plan
Formative & Summative Evaluation
Usability Testing
Simulated Use Human Factor Validation test
Characteristics of the participants
Type of data collected through Usability Test
General Information
General Description
This online & Self-Paced Training Course is focused on the Usability Evaluation for medical devices, according to the requirements of EN ISO 62366, and EU MDR 2017/745 and FDA guideline . 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 different sections, each of the them covering specific topics as outlined in the course contents page.
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.
Course Contents
Introduction to Usability
Terms and Definition
ISO standard related to Usability
FDA requirements
Usability Evaluation Process
Usability Engineering Process
Instructions for Use and Risk Management
Use Specification
User Interface Characteristics
Usability & Risk Management
Hazards and Hazardous Situations related to Usability
User Interface Evaluation Plan
Formative & Summative Evaluation
Usability Testing
Simulated Use Human Factor Validation test
Characteristics of the participants
Type of data collected through Usability Test
General Information
General Description
This online & Self-Paced Training Course is focused on the Usability Evaluation for medical devices, according to the requirements of EN ISO 62366, and EU MDR 2017/745 and FDA guideline . 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 different sections, each of the them covering specific topics as outlined in the course contents page.
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.
Course Contents
Introduction to Usability
Terms and Definition
ISO standard related to Usability
FDA requirements
Usability Evaluation Process
Usability Engineering Process
Instructions for Use and Risk Management
Use Specification
User Interface Characteristics
Usability & Risk Management
Hazards and Hazardous Situations related to Usability
User Interface Evaluation Plan
Formative & Summative Evaluation
Usability Testing
Simulated Use Human Factor Validation test
Characteristics of the participants
Type of data collected through Usability Test
General Information
General Description
This online & Self-Paced Training Course is focused on the Usability Evaluation for medical devices, according to the requirements of EN ISO 62366, and EU MDR 2017/745 and FDA guideline . 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 different sections, each of the them covering specific topics as outlined in the course contents page.
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.
| Topic of the Course | Usability Evaluation for Medical Devices |
| Course Duration | 1,5-2 hours |
| Type of Course | e-Learning, Online & Self-Paced |
| Course Material Available | No (upon request) |
| Transcript Available | No (upon request) |
Course Contents
Introduction to Usability
Terms and Definition
ISO standard related to Usability
FDA requirements
Usability Evaluation Process
Usability Engineering Process
Instructions for Use and Risk Management
Use Specification
User Interface Characteristics
Usability & Risk Management
Hazards and Hazardous Situations related to Usability
User Interface Evaluation Plan
Formative & Summative Evaluation
Usability Testing
Simulated Use Human Factor Validation test
Characteristics of the participants
Type of data collected through Usability Test
General Information
General Description
This online & Self-Paced Training Course is focused on the Usability Evaluation for medical devices, according to the requirements of EN ISO 62366, and EU MDR 2017/745 and FDA guideline . 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 different sections, each of the them covering specific topics as outlined in the course contents page.
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.
| Topic of the Course | Usability Evaluation for Medical Devices |
| Course Duration | 1,5-2 hours |
| Type of Course | e-Learning, Online & Self-Paced |
| Course Material Available | No (upon request) |
| Transcript Available | No (upon request) |
Course Contents
Introduction to Usability
Terms and Definition
ISO standard related to Usability
FDA requirements
Usability Evaluation Process
Usability Engineering Process
Instructions for Use and Risk Management
Use Specification
User Interface Characteristics
Usability & Risk Management
Hazards and Hazardous Situations related to Usability
User Interface Evaluation Plan
Formative & Summative Evaluation
Usability Testing
Simulated Use Human Factor Validation test
Characteristics of the participants
Type of data collected through Usability Test
General Information
General Description
This online & Self-Paced Training Course is focused on the Usability Evaluation for medical devices, according to the requirements of EN ISO 62366, and EU MDR 2017/745 and FDA guideline . 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 different sections, each of the them covering specific topics as outlined in the course contents page.
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.
