System, item and units in medical device software

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  • เผยแพร่เมื่อ 29 มิ.ย. 2024
  • 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: medicaldevicehq.com/iec62304
    Read more about system, item and units in medical software here:
    medicaldevicehq.com/system-it...
    Don't miss checking out the online course Introduction to SaMD and IEC 82304-1:
    medicaldevicehq.com/introduct...
    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
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ความคิดเห็น • 4

  • @santsah1723
    @santsah1723 2 ปีที่แล้ว +1

    Very good explanation! Thank you very much

  • @PaulJones-my4ok
    @PaulJones-my4ok ปีที่แล้ว

    Brilliant Explanation, Thank you

  • @mikkeljakobsen8218
    @mikkeljakobsen8218 ปีที่แล้ว +1

    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?