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

This is an excerpt from the course "Introduction to SaMD, IED 62304 and IEC 82304-1" which is available at: https://medicaldevicehq.com/samd

Don’t forget to check in our course “Introduction to Software Development for Medical Devices and IEC 62304” at:
https://medicaldevicehq.com/introduction-to-software-for-medical-devices-and-iec62304-online-course/

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

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Видео Short course on SaMD (Software as a medical device), IEC 62304 and IEC 82304-1 канала Medical Device HQ