Have you ever had any problems with compliance with IEC 62304? Do you want to apply Agile development principles such as SCRUM when working with medical device software? No problem! In this video, Christian Kaestner explains how to work the way you want and documents how this complies with IEC 62304.

If you're into Agile development, you'll also get a teaser of AAMI TIR 45, which is about “Guidelines for Using AGILE Practices in Medical Device Software Development.”

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

Read more about documenting IEC 62304 compliance and working with Agile here:
https://medicaldevicehq.com/iec-62304-medical-device-software-development-compliance/

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:
0:00 Introduction
0:23 About the instructor
0:40 Meets the requirements of IEC 62304
1:25 Compliance checklist
2:25 Software development processes
5:04 Different development methods
5:52 Standard requirements
6:45 Verification of requirements of the standard
7:46 Scrum and waterfall
9:53 AAMI technical report
11:48 Additional resources

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