It is common to leverage existing software components in medical device software, such as open-source libraries. Software you do not develop yourself is called OTS, Off-The-Shelf, software or SOUP which stands for Software of Unknown Provenance.
This video is about how to document OTS/SOUP software and is the second half on this topic in the online course about medical device software and IEC 62304.
This is an excerpt from the course "Introduction to Software for Medical Devices and IEC 62304" which is available at: [ Ссылка ]
Read more about documenting SOUP and OTS in medical device software here:
[ Ссылка ]
Don't miss checking out the online course Introduction to SaMD and IEC 82304-1:
[ Ссылка ]
Chapters:
00:00 Introduction
00:17 About the instructor
00:46 Basic documentation for OTS software
01:50 Deciding on basic or advanced OTS documentation level
02:16 Description for OTS software
03:37 How to keep track of (control) OTS software
04:10 Risk assessment of OTS software
05:30 OTS software verification / testing
06:25 Assurance of development methodologies and OTS maintenance
07:58 Working with SOUP software
09:17 SOUP maintenance
10:00 Summary
