This is an excerpt from the course "Introduction to Software for Medical Devices and IEC 62304" which is available at: [ Ссылка ]

Read more about classifications rules for medical devices here:
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Don't miss checking out the online course Introduction to SaMD and IEC 82304-1:
[ Ссылка ]

Chapters:
00:00 Introduction
00:10 About the instructor
00:35 Types of classification for medical device software
1:08 Medical device classification
1:24 Classification of medical devices in the EU
2:00 MDR, rule 11
2:40 The US market classification
3:34 Software safety classification
4:25 The correlation between software safety and medical device safety classifications
5:40 Documentation level (FDA)
7:05 Level of concern
7:32 SaMD categorization
9:27 Classification guidance on rule 11
10:22 The importance of criticality
11:05 Classification summary
11:42 Additional resources

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