System, item and units in medical device software

System, item and units in medical device software

5.558 Lượt nghe
System, item and units in medical device software
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