System, item and units in medical device software

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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.

Read more about system, item and units in medical software here:

Don't miss checking out the online course Introduction to SaMD and IEC 82304-1:

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
  1. Medical Device HQ
  2. medical device software life cycle process
  3. medical device software development
  4. medical device software
  5. medical device software engineer
  6. medical device software design
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Very good explanation! Thank you very much

santsah
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Nice explanation. I have some doubts about the "software system" concept and how to apply it. Let's say we have a medical device consisting of multiple embedded devices, each running their own applications that fulfills some part of the system requirements. Would each device represent a software system or a software item within a single software system? And is there any point in making such a division in this scenario?

mikkeljakobsen