Are you struggling with the terms software unit, item, and system in IEC 62304? In this video, the “Brickman” will assist me in explaining these essential terms when developing medical device software.
I also encourage you to define your software system with care and make sure to exclude software functionality which doesn’t have any medical device features.
This is an excerpt from the course "Introduction to Software for Medical Devices and IEC 62304" which is available at: https://medicaldevicehq.com/iec62304
Read more about system, item and units in medical software here:
https://medicaldevicehq.com/system-item-and-units-in-medical-device-software/
Don't miss checking out the online course Introduction to SaMD and IEC 82304-1:
https://medicaldevicehq.com/introduction-to-samd-iec62304-and-iec-82304-1-online-course/
Chapters:
00:00 Introduction
00:13 About the instructor
00:35 Three important terms
01:17 Software system and item explained
03:16 Units and documenting the architecture
05:41 Applying the terminology
06:57 Practical example
08:58 Additional resources