Medical Device Software Verification & Validation
| Topic of the Course | Medical Device SW Verification & Validation |
| Course Duration | 4 – 4.5 hours |
| Type of Course | e-Learning, Online & Self-Paced |
| Cost | 159,00 (VAT Excluded) |
Course Contents
Section 0 – General Introduction to the Course
Course Description and Duration
Structure of the Course
Objective of the Course
Assessment of Learning AchievementsPrerequisite
Course Certificate
Section 1- Introduction to Design& Development for SW Medical Devices
Introduction to Design and Development
Verification and validation
Waterfall vs Agile Development
Section 2a – SW Risk Management & General Requirements of IEC 62304
Key Definitions
SW Risk Classification
General requirements IEC 62304
Section 2b – SW Development Plan and SW Requirements
SW Development Planning
SW of Unknown Provenance
SW Requirements
Section 2c – SW Architecture, SW Unit Implementation and Integration
SW Architecture
SW unit Implementation
SW integration and Integration Testing
Section 2d – SW Configuration Management and SW Problem Resolution
SW Configuration Management
SW Problem Resolution
SW Risk Management (part 2)
Section 3 – IEC 82304 and Health Software
Health SW Life Cycle
Health SW Validation
SW integration and Integration Testing
Health SW Accompanying Documents
General Information
General Description
This online & Self-Paced Training Course is focused on Medical Device Software Verification and Validation, according to the requirements of IEC 62304, IEC 82304-1 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 interested in V&V activities for Software medical devices, either embedded or stand-alone SW.
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 six 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.
