This is an excerpt from the course /"Introduction to Medical Device Software and IEC 62304/" available at: https://medicaldevicehq.com/iec62304

Read more about classification rules for medical devices here:
https://medicaldevicehq.com/introduction-to-different-classifications-rules-for-medical-device-software/

Don't miss the Introduction to SaMD and IEC 82304-1 online course:
https://medicaldevicehq.com/introduction-to-samd-iec62304-and-iec-82304-1-online-course/

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

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