Short course on SaMD (Software as a medical device), IEC 62304 and IEC 82304-1

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  • เผยแพร่เมื่อ 15 มิ.ย. 2024
  • This is an excerpt from the course "Introduction to SaMD, IED 62304 and IEC 82304-1" which is available at: medicaldevicehq.com/samd
    Don’t forget to check in our course “Introduction to Software Development for Medical Devices and IEC 62304” at:
    medicaldevicehq.com/introduct...
    Chapters:
    00:00 Introduction
    00:24 About the instructor
    01:12 Course goals
    01:40 Working with medical device software vs medical devices
    02:00 Medical device development vs software development
    03:56 Software release vs product release
    05:04 Software as a medical device release flow
    05:54 Software release and design release
    06:28 Six essential standards for SaMD
    07:00 Management standards: ISO 14971 and ISO 13485
    09:08 IEC 62366-1 standard for usability engineering and user interfaces
    09:54 IEC 81001-5-1 standard for security for standalone software
    10:07 IEC 82304-1 standard for standalone health software
    11:52 IEC 62304 standard for requirements and activities
    13:57 The scope of the 62304 standard
    16:56 Working with agile vs waterfall development methods
    18:56 Software development planning for a SaMD project
    21:44 Software configuration management
    24:52 Risk management in software development
    27:23 Additional resources
    Don't forget to follow Medical Device HQ on LinkedIn:
    / medicaldevicehq
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ความคิดเห็น • 6

  • @mahimametal
    @mahimametal 2 หลายเดือนก่อน

    This was wonderful and very helpful. Thank you!

  • @user-gr8tl7vh7d
    @user-gr8tl7vh7d 9 หลายเดือนก่อน

    Great video, thank you so much for sharing!

  • @habenbemnet4911
    @habenbemnet4911 ปีที่แล้ว +1

    Shouldnt the title of this video include IEC 82304-1 insted of IEC 82301-1?

  • @user-in9hv4wp4l
    @user-in9hv4wp4l 13 วันที่ผ่านมา

    12:30